ION 2011-002 on the Code of Health EXPLANATORY MEMORANDUM The Act on the Code of Health, which is the subject of this Explanatory Memorandum is to replace Order No. 62072 of 29 September 1962 codifying the laws regarding Public Health. Over fifty years have passed between the two codes during which important data having impacts on the evolution of population health intervened. New institutional and administrative structures have been put in place. The responsibilities of the Ministry of Health has increased considerably, while significant progress has been made in the fields within the Ministry of Health. The design of the National Health Policy was itself heavily influenced by the basic texts of national and international law, the main deserve mention. In the field of international law and in the fifty years between the two codes, important international conventions ratified by Madagascar, which invite all States Parties to fulfill their health policy tangible progress. Include in particular the Universal Declaration of Human Rights, Article 25: 1) "Everyone has the right to a standard of living adequate for the health and well-being and that of his family, including ... medical care and necessary social services ... 2)" motherhood and childhood are eligible for assistance and to special assistance. " In the International Covenant on Economic Social and Cultural Rights, it may be noted that Article 12 provides: "1. States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest physical health mental and it is capable of achieving. 2

2. The measures that States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for: a. the reduction of the stillbirth and infant mortality and for the healthy development of the child; b. improving all aspects of environmental health and industrial hygiene; c. prophylaxis and treatment of epidemic, occupational and other as well as fight against these diseases; d. the creation of conditions to ensure that all medical service and medical attention in case of illness. "

The National Plan The Constitution contains some provisions for the protection of the individual and his health. One can mention the provisions stipulating that the "State recognizes and organizes every individual the right to protection of their health at conception," and also that "the State shall ensure the protection of the family for its free development and that the mother and child by legislation and by appropriate social institutions. " The Government is committed to achieving a real and tangible development by giving priority to Transformational Reform Initiatives. Proceeding to the analysis of poverty, the Government outlined the strategies and the various actions that will lead to rapid economic growth, contribute to the reduction of poverty and enable the country to benefit from the challenges of globalization, in line with objectives Millennium Development. Strategies and projects of the National Health Policy includes 8 commitments, are designed essentially to effective poverty reduction and a tangible improvement in the quality of life of Malagasy. Specifically concerning the Health / Population pane, the Government is constantly concerned to maintain healthy population, that is to say in a complete state of physical, mental and social. Indeed, such a population can contribute to the development of the nation and lead long and fruitful lives. It thus constitutes the fundamental lever of development. It is therefore understandable that the Government, taking into account the latest available data on the health status of the population and especially of the most vulnerable social groups, defined the broad outlines of a health policy which includes Health the Family Planning and the Fight against HIV / AIDS. The Health Sector action program focused on eight components (8) which: 3

• ensure the provision of quality health services to all; • eliminate the major communicable diseases; • win the fight against HIV / AIDS; • implement an effective strategy for family planning; • reduce child mortality; • reducing maternal and neonatal mortality; • improve nutrition and food security; • supply the population with drinking water and generalize hygienic and sanitary practices. Thus, the problems of malnutrition and malaria will be resolved; trend of the spread of HIV / AIDS will be reversed; drinking water will become accessible and the average size of the Malagasy family will be reduced through education and the provision of health services. Taking into account these different statements, but especially the new socio economic context which the Government faces, the Ministry of Health has decided to implement a new Code of Health, inspired preparations dating back to various workshops organized in 1997 but considerably enriched through collective reflection involving the active participation of the Departments, Services and Partners. The goal is to put in the hands of health professionals and the service of the population, an updated legal instrument, credible and accessible for all. The content of the Act The Act Health Code includes 360 articles, 117 articles against the former Code of Public Health. Furthermore, it should be noted that, in accordance with the provisions of the Constitution

On the area of ​​law and regulation, the new project mainly defines the general principles of the organization and operation of the Health Sector. It should be completed by decrees or orders concerning the implementing rules and regulations that are not necessarily of general principles. The 360 ​​articles of the new Code are divided into 10 books that have been in the possible, logically classified and which were inserted new elements aspiring to enrich the National Health Policy. Preliminary Book is new in the presentation of the Code because it brings together various fundamental rules of the overall organization of hospitals and health services in accordance with the National Policy Hospital Reform. It introduces new requirements for Hygiene and Health Committees, establishes the creation and powers of the Medicines Agency of Madagascar confirms the modalities or delete care and integrated in the new requirements of the Code for Telemedicine. 4

The First Book summarizes the basic rules of the general protection of health. Sanitary and general hygiene, previously scattered in various texts, are grouped, while guidance on the overall direction and a logical classification of health and safety measures are clearly highlighted. Important innovations were introduced in the first book, including that relating to the protection of the environment and that concerning health control at borders whose provisions were strengthened. Book II is devoted to medical, paramedical and traditional medicine . Alongside the provisions already known but specified, innovations have been introduced concerning the profession of paramedics and the recognition of the legality of the practice of traditional medicine, including proper legal limit recognition to prevent the proliferation of quackery in the profession. Book III relates to medicines, the pharmacy and the conditions for exercising the profession of pharmacy . Innovative rules concern national drug policy, the definition of medicines, clinical trials, advertising, import establishments of wholesale sales, in particular management pharmacies, traditional medicine and the liberalization of transactions involving the sale of drugs and other health goods. Book IV resumes in an order that normal-qualified them terms of fight against contagious diseases services. In addition, the case of other emerging and reemerging diseases is discussed, and a special mention regarding diarrheal infectious diseases, including cholera and the sexually transmitted diseases. Book V For noncommunicable diseases but strengthens provisions chronic and disabling diseases, eye diseases, the fight against drug addiction and mental illness, not to mention the oral health. Book VI requires special attention as it contains fundamental provisions from international conventions on the protection of the family and child. In addition, it introduced innovations in reproductive health and school and university health. It incorporates the Code of the National Nutrition Policy and the Expanded Programme on Immunization. Book VII reinforces the provisions already known but requiring clarification

On clinical laboratories, the blood and blood products and the control of the handling of microbial products. Particular attention was paid to the provisions to govern blood transfusion. The Book VIII fixed the classification of personal responsibilities under the Ministry of Health as well as those of its providers and sacntions arising in case of failure. 5

The Book IX includes disciplinary punishments and measures in case of infringement. Punishments and measures disposed in accordance with all health sector stakeholders, given the seriousness of the offenses committed when it comes to activities related to public health. Book X is on diverse and transitional provisions. It provides for transitional arrangements must be designed or maintained pending the effective implementation of the future structures of the Fourth Republic. This is the purpose of this Act. 6

REPOBLIKAN'I MADAGASIKARA Fitiavana-Tanindrazana-Fandrosoana

ION 2011 - 002 on the Code of Health The Congress of the Transition and the High Council of the Transition adopted in their respective meeting dated 24 May 2011 and 27 May 2011, the law which reads as follows: BOOK OF PRELIMINARY 'INSTITUTIONAL AND ADMINISTRATIVE ORGANIZATION OF MEDICAL SERVICES OF MADAGASCAR Article premier.- This book is devoted to the general presentation of institutions and administrative structures together constituting part of in which health and medical services operate in partnership with private organizations and civil society and consistent with the Regional and Local Authorities.

TITLE I INSTITUTIONS Article 2. The organization of all medical and administrative services is set by Orders in Council of Government on proposal by the Minister for Health and possibly by Decrees and Circulars issued in application of these decrees. The organization and duties of the various Councils and Commissions are established by decrees issued by the Council of Government on the proposal of the Minister of Health. Article 3.- The National Committee of Hygiene and Health, unique body that replaced the Higher Committee for Hygiene and the National Commission of Hospital Organization, will be subject to a decree of the Council of Government on the proposal of Minister of Health, strengthening its organization and specifying its composition, role and functioning. The Committees of Hygiene and Health, which replaced the Provincial Committees of Hygiene at the regional or municipal level are strengthened in their composition, role and functioning by Decree of the Ministry of Health. TITLE II AGENCY DRUG MADAGASCAR, AGENCIES AND UNITS CONTROL AND PRODUCTION Article 4. As part of the implementation of the National Pharmaceutical Policy, the Minister for Health gives the "medicines Agency of Madagascar" Public Establishment Administrative character with legal personality and financial autonomy, implementation of mission and quality control of medicines in Madagascar. 7

The establishment of the Agency Drug Madagascar is fixed by decree Government Council on proposal of the Minister of Health. Article 5. The duties of the Agency of Medicines of Madagascar whose enumeration appears in Title IV of Book III of this Code are intended to:

- To guarantee the independence, the scientific competence and administrative efficiency studies and controls on the manufacture, testing, therapeutic properties and the use of medicines; - To ensure the best cost health and safety of the population; - Contribute to the development of industrial and pharmaceutical research; - Instruct inspectors pharmacists under his authority the enforcement of laws and regulations relating to the drug and the exercise of the profession of pharmacy. Article 6. It is created within the Ministry of Health an Agency of Sanitary Safety Control and Foodstuffs Quality (ACSQDA). It is a public institution Administration (EPA) with the legal entity and the legal and financial autonomy. Article 7. The Agency for Hygiene Control and Foodstuffs Quality mission is to protect the health of consumers by ensuring that food consumed, distributed, marketed or produced in Madagascar are consistent with national and international standards in food safety and food hygiene. Article 8. Any inspector of the Health Safety Control Agency and Quality of Foodstuffs has standing under the provisions of Article 199 of this Code in the food control area and to, food fraud. The terms of organization and functioning of the Agency for Sanitary Security Control and Foodstuffs Quality and those of its bodies are established by decree of the Council of Government on the proposal of the Minister of Health. Article 9. It is created within the Ministry of Health a Production Unit and Supply Solutes in Massive. It is a public institution of industrial and commercial (EPIC) with the legal status and the legal and financial autonomy. Article 10.- The Production Unit and Supply Fluids Solid is responsible produce massive solutes and para-pharmaceutical products such as disinfectants, antiseptics and to ensure the supply to of Health Facilities. This provision is intended as a priority to meet the needs of public health institutions, and second, to those of private health facilities. creation of the conditions, organization and operation of this unit Production and Supply of Fluids Solid and those of its bodies are established by decree of the Council of Government on the proposal of the Minister of Health.

8 PART III CARE FACILITIES Article 11.- As part of the implementation of the Hospital Reform, it is created with of the Minister of Health Hospital a National Agency, which include the following tasks: - Hospital Reform control and monitoring of its implementation; - Be an Observatory for the implementation of the new statutes of Public Hospital Establishments and related bodies; - Be an Observatory hospital system for analysis, monitoring and evaluation hospitals in support of the Central; - To conduct strategies to develop design studies; - Give opinions at the request of the Minister of Health especially on major issues of hospital national policy. The status of this Hospital National Agency, the composition and terms of appointment of members, powers and operating methods are set by regulation.

Article 12.- The organization of care in the public sector is organized on four levels: - basic health facilities to the first contacts: Basic Health Centres Level 1 and Level 2 (CSB1 and CSB2) ; - Hospital complexes District Reference (CHRD); - Hospitallers centers Regional Reference (CHRR) - The University Hospital (CHU). The first level of the health pyramid includes CSB1 the CSB2. They ensure the supply curative, preventive and promotional databases. Article 13.- The Hospital Reform plans in the national hospital map that Public Hospital Establishments are organized in University Hospital Centre (CHU) in Hospital Regional Reference (CHRR) and Hospital District Reference (CHRD ) according to their location, the legal, administrative and technical. The Public Hospital Establishments first level (District) priority in providing general medical services, general surgery, obstetrics and emergency care. They are called "Hospital District Centres of Reference" (CHRD). The Public Hospital Establishments second level (Region) dispense medical services and general surgery, obstetrics, specialty, emergency and specialized care for medical and surgical character. They are called "Regional Hospital Centres of Reference" (CHRR). The Public Hospital Establishments third level have a care vocation hard extends throughout the national territory, due to their high specialization in medicine, surgery, obstetrics, and specialties. They are intended to provide practical training to university and post-graduate and research. These are the "University Hospital" (CHU). Article 14. The University Hospital (CHU) and Hospitallers centers Regional Reference (CHRR) is made a national public establishments to 9 character

Administration (EPA) with the prerogatives and obligations s 'y related, according to the provisions of Law No. 98-031 of 20 January 1999 on the definition of Public Institutions and rules concerning the establishment of Public Institutions category and its regulations thereunder. Hospital complexes District Reference retain their status and related services under the administrative, technical and financial authority of the Ministry of Health. Article 15.- The private sector provision of care is organized in: - Basic private health facilities that include nursing stations, delivery stations, medical offices, private clinics, private health centers; - Private Hospital Establishments care that are clinics, polyclinics, private hospitals. The clinic is a facility that is practiced only one medical specialty. The polyclinic and the private hospital are institutions which are practiced several medical specialties. They are classified Hospital Establishments Private for-profit or Hospital Establishments Private nonprofit whose technical supervision is exercised by the Ministry of Health.

Article 16. The proposed creation or suspension of a hospital, a hospice, a maternity, a delivery station, a clinic or other health care facility can be decided by the administrative authority under which the establishment after approval of the Minister of Health, on the advice of the Commission for the opening and closing of public and private health establishments. As necessary, a statutory fixed the organization and functioning of the Commission aroused. The opening privately a clinic, a clinic, a birthing facility, a psychiatric hospital or a hospice is subject to prior authorization of the Minister of Health, after consulting prompted the Commission. Are subject to the authorization of the Ministry of Health: - creation; - Extension; - Retraining; - The total or partial cancellation; - Grouping all Formations private washrooms. Article 17. In accordance with the legislation in preparation on Technologies of Information and Communication (NTIC), news, laws and regulations must be taken at the behest of the Minister of Health regarding the telemedicine. These arrangements shall include all necessary instructions for the proper functioning of the transmission by the Information Technology and Communication, medical information in order to obtain remote diagnostics, expert advice, monitoring of a patient or a treatment decision. They must also provide for the establishment of a Technology of the supervisory body of Information and Communication in the field of health and to ensure respect for confidentiality.

10 FIRST BOOK OF THE GENERAL HEALTH PROTECTION Article 18. This Code defines, by discounting the fundamental principles in the context of the National Health Policy, sanitary and general hygiene landscaping and improving access of the population to services health, protecting against diseases and strengthening the establishment and organization of structures designed to implement action programs in all health areas. It brings together in a coherent and unique instrument essential rules for medical, paramedical and pharmacists.

TITLE OF HEALTH AND HYGIENE MEASURES GENERAL FOR THE NATIONAL TERRITORY Article 19.- The sanitary and hygienic winning in the national territory and the procedures and sanctions to ensure their application result: - International Conventions, declarations or treaties whose provisions health matters bind the Republic of Madagascar under the rules of Public International Law; - The implementation of this Code and its laws or regulations applicable; - Applicable laws and regulations in the national territory and which include sanitary and hygiene. CHAPTER HEALTH REGULATIONS Article 20. Under the provisions of Law No. 2004-001 of 17 June 2004 on the Regions and those of Article 358 of this Code, it is the authorities of the Decentralized Territorial Communities who are empowered to monitor the implementation of the provisions of health regulations in their respective territorial or local jurisdiction. Section 1 From the general direction of contents of health regulations Article 21. The health regulations determine in particular:

1- measures to be taken in the framework of laws and regulations to prevent or stop communicable diseases in general; 2- effective measures to implement in case of threat or epidemic diarrheal diseases, including cholera; 3- protection of foodstuffs and precautions for their sale under the conditions that are necessary to preserve the health of consumers; 4- disinfection or destruction of objects used for sick or have been soiled by them and generally, things that may carry contagion.

11 Article 22.- The health regulations must also include: 1 requirements for the safety of all residential buildings and non-farms and their dependencies, private roads, closed or not at their ends, irrigation canals and drainage, housing rented furnished, hotels and restaurants; 2- the requirements for safety areas; 3- the requirements for drinking water and monitoring wells and laundries; 4. the requirements for waste materials and the conditions to be met by cesspools; 5- the requirements for the safety of schools and universities; 6- requirements related to the protection of the population to health risks related to the environment, including those related to health care waste. Article 23. At the level of municipalities, the Mayor takes on participative proposal Fokontany after consulting the Communal or Municipal Council of Orders for the purpose such special as it deems fit without prejudices of the International Health Regulations or the provisions of this Code to ensure the protection of health within the constituency of his municipality. Section 2 In the fight against epidemics through prevention Article 24.- In case of threat of epidemic determined, usually in a region or locality recognized high risk of spread of the disease, the Minister of Health may order, by Decree, the requisition of vaccine stocks against the epidemic in the regions have supply centers, whether public or private. The conditions under which the requisition is to be performed are specified in the aforementioned regulation. To prevent the spread of contagious diseases, the following measures should be taken: - a list of communicable diseases to which apply the provisions of this section is compiled by the Ministry of Health, by regulation; - Contagious diseases are subject to a mandatory declaration drawn up by regulations. This list may be amended or supplemented in the same way; - Are subject to mandatory reporting of data to the health authorities by healthcare professionals, public or private and heads of public and private medical biological analysis laboratories: • diseases that require localized urgent intervention; • diseases that require urgent action at national or international level.

12 Article 25.- The declaration to the health authority of any case of one of the diseases on the list referred to in Article 24 is mandatory for any doctor or any paramedic, Chief Training of Health, which has found to exist. The declaration must state the causes leading to the death and the source of the infection. In order to prevent any spread of a contagious disease in evolution, the Minister

For Health may make an Order Establishing the health alert in a locality or region threatened to organize health monitoring. The health alert is set for a fixed but can be extended period; hygiene and disease prevention measures may be made mandatory. CHAPITTRE II OF HEALTH MEASURES Article 26.- The health measures provided for in this Code and supplementing health regulations mainly concern the management and control of water, disposal of waste of all kinds, protection of food, sanitary conditions of housing and environmental protection. Section 1 From management and water control Article 27. Water is a public good in the public domain. The declaration of public utility of sources as well as easements and rights hereunder shall be governed by the laws in force in the matter, and in particular by the provisions of Law No. 98-029 of 20 January 1999 on the Code of the water. Groundwater is formed by the water contained in the aquifers and springs. They are part of the public domain as well as surface water. Article 28. In accordance with specific provisions of Law No. 90-033 of 21 December 1990 Charter of Environment, Law No. 98-029 of 20 January 1999 on the Water Code and the Law No. 99-021 of 19 August 1999 on the management and control of industrial pollution policy, hygiene measures to protect drinking water and the elimination of all sources of water pollution are part of the action general health protection wherever they take shelter of pollution of water resources and where they preserve drinking water in quantity and quality. The water potability standards are defined by decree of the Council of Government on the proposal of the Minister concerned. All water intended for human consumption must be physico-chemical and bacteriological analysis by accredited laboratories by the Ministries of Health and Water. Article 29. Pollution means any spills, discharges, releases, direct and indirect deposits of materials of all kinds and more generally, any facts that may cause or increase the degradation of the environment, especially water degradation by modifying their physical, chemical, biological or bacteriological and radioactive, whether surface water or groundwater.

13 Any natural or legal person, public or private, carrying out an activity, source of pollution or potentially dangerous to water resources and environmental health, has the obligation to take into account in personal activity or in the overall management of the business, the environmental impact of its activities on the surrounding environment and take all appropriate measures to prevent, mitigate or eliminate the alleged danger, threatening or effective. Article 30.- Regarding particularly wastewater other than domestic, and without prejudice texts in force the provisions establishing the Code of Urbanism and Housing concerning the discharge of waste water and materials, celles- it should in no case flow in gutters or public sewer unless authorized by the competent authorities. Article 31. Anyone who through negligence or carelessness degrades public works or

Communal for receiving or driving wastewater leaves introduce waste or droppings from any source whatsoever, or any other matters that could affect the safety of the environment, including water sources, fountains , wells, tanks, pipes, aqueducts, reservoirs of water for public supply, is liable to the provisions of Article 329 of this Code. If the responsibility of a corporation or other legal entity, the liability enacted under Article 329 the aforementioned outweighs criminal responsibility. Section 32 shall be prohibited, on pain of the same sanctions under Article previous , abandonment of dead animals, debris from butchers, manure, feces and generally organic residues, putrescible in faults or excavations could contaminate water supplied for drinking and consumption. Any burial outside surfaces authorized for this use is also prohibited. Article 33. accordance with the provisions of Law No. 94-027 of 17 November 1994 Sanitation Code, safety and the working environment, workers should have at their disposal drinking water . The water that does not come from an officially authorized service drinking water should not be distributed as drinking water. Drinking water is defined as water intended for human consumption and, by treatment or naturally meets standards organoleptic, physical-chemical, bacteriological and biological fixed by decree. The supply of public drinking water and access to public sanitation Domestic wastewater water are provided by the Public Communal Service. It belongs to the Municipality concerned, both in urban and rural areas, to provide the unserved areas of drinking water supply facilities to extend the service rate and to raise the current rate of sanitation coverage. Water consumption, bottled or unbottled, must be checked regularly by laboratories approved by the state. The organization and the designation of the organizations concerned are fixed by decree of the Council of Government on the proposal of the concerned ministries (Health, Energy, Water) specifying their roles and functioning.

14 Section 2 Waste Management

Article 34.- Waste which is likely to pollute water and, in general, threaten or harm the health of humans, should be removed to reduce air pollution, water as well as environmental degradation. The waste consists of residues of an industrial transformation process of use of all substances or materials from a production activity, waste hospitals and health structures and chemical and pharmaceutical residues. Personal property abandoned, industrial solid waste, whether ordinary or special, shall be destroyed and disposed of, or by any persons or entities that generated them or by the Regional and Local Authorities within of road, sanitation, hygiene and removal of waste which they are responsible, and within the limits of their authority. Article 35.- The waste from hospitals and health structures are sometimes contaminated (potentially infectious) and sometimes not contaminated. Contaminated waste, if not eliminated with the right precautionary measures required, may carry microorganisms that can infect people who come into contact with the waste and the entire community. Are considered contaminated elements: blood, pus, urine and other body fluids and any other body that comes in contact with its elements. Waste from treatment rooms, delivery rooms and operating rooms should be considered contaminated. It will be necessary to neutralize, evacuation or isolation of as quickly as possible, all waste and debris that could generate unpleasant, toxic or dangerous, or be a source of infection. In accordance with the National Policy on Waste Management of Health and Safety of Injections institutions, each health facility is required to manage medical waste. The technical rules for sorting, collection, storage, transportation and disposal must be in place to ensure the protection of users, staff and the community and the environment address health and environmental risks. Presorting must be established in schools to ensure separate management of waste according to their nature and the risks involved. A waste management plan must be drawn up and implemented in each institution. Article 36. It is the natural or legal persons whose activities are the cause of ordinary or hazardous solid waste reuse in the circuit ensuring the protection of the environment by all means as modern and accessible technical start scope: central storage, recovery, recycling, incineration, landfill, composting. Article 37.- Solid industrial waste called "special" should be distinguished because of their toxicity and the dangers they pose to the environment, particularly for the water they can pollute with pathogens of infectious diseases they may raise and convey.

15 They should be subject to special measures provided for by Law No 99-021 of 19 August 1999 on the policy of the management and control of industrial pollution: secure storage, disposal of regulated facilities for this purpose and the responsibility of authorities.

Article 38. The Municipalities are in charge of arrangements to ensure the removal and disposal of waste and scrap. To this end, they coordinate the action of Fokontany which are the basic administrative subdivisions in the Commons and participate and contribute permanently and effectively to social mobilization and community development on health and the preservation activities of the environment and its components. Article 39.- The industrial or managers of companies whose activities are the source of waste and debris, should have to bear the expenses related to the implementation of the disposal measures of waste and scrap, under pain of the sanctions provided by Article 329 of this Code. Hazardous solid or liquid wastes should be a list of special treatments and governed by regulations implementing international agreements. Section 3 From protecting food supplied for consumption

Article 40. Under this Code, the term 'food' any substance processed, semi-processed or raw, for human consumption, which includes drink, the "chewing gum" and all substances used in the manufacture, preparation and processing of food to the exclusion of substances used only as drugs, cosmetics or tobacco. Article 41-. Without prejudice to specific legal provisions on consumer protection and in accordance with the Codex Alimentarius standards that require to consumers healthy food and safe and nutritious food, the locations where are manufactured, handled, stored or put food on sale must be kept in a clean state free from rodents, insects and pathogens of any animal vectors. Specifically, the manufacturing, processing and marketing of drinks groups defined in Section 1 of Ordinance No. 60-098 of September 21, 1960 as amended, concerning the regulation of drinks, remain subject to the authorization of the said Order regime. Article 42. In general, the issue of consumability Certificate must comply with the laws and regulations. Notably, while agri-food business and food importer must submit for testing their products and the analysis results must be sent to the Agency for Hygiene Control and Foodstuffs Quality for deliverances of consumability a certificate for each production lot of food before being placed on the market. Article 43.- The Agency for Hygiene Control and Foodstuffs Quality has a laboratory that control the quality of local production of food imported and compliance of hygienic products not food such as detergents, placed on the market in Madagascar. 16

The Control Agency for Hygiene and Foodstuffs Quality may be used, if necessary, to the provision of other approved laboratories. The mission and functions of the Office of the Food Standards Agency and the inspection service are defined by statutory instrument made by the Minister of Health. Article 44.- Any company manufacturing, handling and any place selling foodstuffs must satisfy respectively in respect to necessary conditions and measures to ensure the safety, soundness and safety of these foods since their production, preparation, processing, storage, transportation and marketing. The modalities of the transport of foodstuffs, packaging products and measures for putting food on sale will be determined by Decree of the Council of the Government on the proposal of the Ministers concerned. Manufacturing, processing and marketing of tobacco products, alcoholic beverages such as those of soft drinks must comply with the laws and regulations on the subject, on pain of being forfeited, without prejudice to the sanctions provided for effect by laws and regulations. Article 45.- Every person working in a manufacturing company, handling of food is required to comply with sanitary control measures and mandatory vaccination could be enacted by the Minister of Health. Article 46.- In accordance with the specific legal provisions relating to consumer protection, particularly as regards prevention, products and services must have the necessary security guarantees in terms of the preservation of the health of the consumer, and that, from the first placing on the market: products must comply with the conditions set by law and regulations relating to safety and health. The registration of all food establishment is required. Accordingly, any food establishment, catering and food importer must be registered and declare their products placed on the market with the Control Agency of Health Security and Foodstuffs Quality. These measures aim to ensure the control and quality of food available for human consumption in the territory of the Republic of Madagascar, and to avoid possible risks of poisoning likely negative impacts on public health. Clearance or the sale of food can be made when the importer or vendor is in possession of documents certifying that they are fit for human consumption and can be put into marketing. These documents are issued respectively by the Ministry of Health and by the Ministry of Commerce. Article 47.- The food products of animal origin from animal groups fed in concentrated protein essential that the cases of the disease Stephen Jacob commonly called "mad cow" has been screened or not in the bovine are declared unfit for human consumption and prohibited the sale commercially in Madagascar. 17

Food products of animal origin derived from animals struck with deadly epidemic disease in animals, may contaminate or lower risk for serious, man, whatever the causative organism and especially for FMD and flu bird, are declared unfit for human consumption and donations given against the Food and banned the sale and entry into the national territory. Article 48.- The food products of plant origin, having been cultured under specific mode of genetically modified organisms called GMOs, the subject of a declaration placing them dangerous for human consumption due to the potential for changes in genome they pose to consumers. Their sale under food is prohibited throughout the national territory. Article 49.- The rules implementing the provisions of sections 41 to 48 will be determined by regulations. Specifically, as regards the provisions of Article 47 of diseases deemed contagious animals that are laid down by texts in force establishing the nomenclature of animal diseases deemed contagious Madagascar and / or any amendments thereto. In the interest of consumers and more effective protection of the population against harm to health, the violation of the provisions of sections 41 to 48 constitute the offenses punished by criminal laws and is subject to the effect of specific legislation. Section 4 Hygiene measures chemical preparations and substances for public health use and management of the safety of air Article 50.- The standardized labeling packaging of substances and preparations for domestic and public hygiene is governed by the provisions of the regulations in force, issued by the Minister of Industry, Trade and Development Private Sector and possibly by amending the regulations. Article 51.- The chemical substances intended for use in public health, including those aimed intra-domiciliary treatment must have the approval of the Minister of Health before being imported, manufactured or reformulated for placing on the national market. Are part of these preparations, soaps and detergents, all products intended for the fight against insects and pests, disease vectors, regardless of the formulation in which they are presented, the active substance used and the concentration. This approval results in issuing a marketing authorization. The rules implementing the provisions of Articles 50 and 51 are made by regulation. Atmosphere should be healthy. Any activity that pollute the air and, in general, threaten or harm the human health, must be controlled to reduce the pollution and degradation of the environment. The air component concentration standards should be set by decree on the proposal of Ministries of Health and Environment.

18 CHAPTER III SANITATION OF HOUSING SITES Article 52. All the places, buildings, buildings, cities, towns and rural areas designed to serve residential and for this purpose, to be filled community facilities and health infrastructure and consolidations within the requirements on the hygiene of housing, must be constant concerns of governments that are observed: - the texts in force the provisions establishing the Code of Town Planning and housing;

- The provisions of Law No. 98-029 of 20 January 1999 concerning the Water Code; - The provisions of the implementing legislation of the aforementioned law; - The provisions of international health regulations at the national level and that of Regional and Local Authorities. Section 1 From the safety of buildings Article 53.- Without prejudice to the provisions of the Code of Town Planning and Housing on the health conditions of the buildings and relative safety when building built or not, adjoining or not on public roads, is either by itself or by the conditions in which it is held, a threat or danger to the health of the occupants and neighbors, the mayor, or failing that, the supervisory authority, seized by a reasoned report of the health authority or Municipal Office of Hygiene concluding the danger presented or unhealthy of all or part of the building is required to invite the Municipal Health Committee and Health interested to give its opinion within two (02) months: 1 on the reality and causes of unhealthy; 2 on measures to address them. In which the reality of the danger or unhealthy and unable to address them have been found , the Mayor or, failing that, the supervisory authority shall, within one (1 ) months of rule by decree the permanent housing ban. The Order must specify whether a permanent ban is applicable or immediate departure of occupants within a specified period. Article 54.- In case the opportunity to correct the hazard or unsafe was found, the Mayor or, failing that, the supervisory authority shall, within a period of one (1) month by Decree prescribing the appropriate measures necessary and the time limit. The temporary housing ban may be decided by the competent authority. however it will end as soon as it is established that the measures prescribed by the Mayor or the health authority has been completed. Article 55. Any occupant of a substandard building that was the subject of a decree definitive or temporary housing ban and do not comply with said Order is subject to an expulsion pronounced at the request of the authority referred to in Article 53 of the Ordinance by President of the Court.

19 In case of emergency or serious danger and after man's relationship to the art on the state of the building, the authority referred to in Article 53 can execute to office, at the expense of the owner and possibly the tenant who has not performed the within the time granted to it, the measures necessary to safeguard public health. When as a result of the application of Articles 53 and 54 of this Chapter applicable to termination of leases, such termination shall not imply, in favor of tenants, no damage interest. Article 56.- The expenses resulting from the execution of works are secured by a lien on revenues of the building, which is subordinate to the privileges set forth in Article 2101 of the Civil Code as yet applicable in the territory of the Republic. Section 2 safety centers

Article 57.- Without prejudice to the application of existing texts of the provisions laying down the Code of Urbanism and Housing and in accordance with the provisions of Law No. 98-029 of 20 January 1999 on the Code of water, sanitation and urban areas all appropriate steps to eliminate the unhealthy condition affecting the protection of water resources, health and safety of people must have is to ensure the drainage of rainwater and wastewater and their releases to the natural outlets in the manner compatible with the requirements of health protection. For this purpose, any building can be built on the area originally planned to serve as public roads and lined with waste water evacuation systems. Article 58. In cities where adapted the separate system, two different lines may be imposed. The waters and materials will be disposed in such a state that they can not cause any nuisance. The same provision will be taken: - any old building, occasionally heavy repairs; - For all the buildings lacking cesspool or with a non-tight tank or installed in contravention of the requirements of sanitary regulations; - For all the buildings already attached to the storm drains for wastewater. Article 59.- A default by the owner of complying with the obligations imposed by the previous article, the taxes that cities are authorized to collect on claims of the owners of tracks with sewers, are increased by 50% from the time the connection has been made, and that the expense of the owner recalcitrant. In addition, the normal connection can be made automatically by the Mayor of care in the forms and conditions laid down by Section I of Chapter III of this First Book. Article 60.- The Commons may, to facilitate their rehabilitation or development , causing unsanitary declaration of a building or group of buildings, 20

especially if threat presented by the building or group of buildings to the lives of occupants and residents. Unsafe or threat signaled by an opinion of the Office of Hygiene or the Hygiene and Health Committee is terminated by a decision of the Municipal Council concerned, supported by a plot plan of buildings, specifying the names owners, as contained in the matrix of roles and, where appropriate, on a development project. A decree of the Council of the Government sets the rules for implementing this Article . Article 61. If for a specified period following the recorded causes or during a sudden change of the demographic curve, the number of deaths in a Municipality exceeded the figure of the average mortality, the municipal authorities are required to entrust the Committee of Hygiene and Health to conduct the load or make an inquiry on the health conditions of the Commune. If the investigation establishes that the health status of the Commune requires work

Sanitation, especially that it is not provided with drinking water of good quality and in sufficient quantities, or that the water remains stagnant there, creating dangers or drawbacks for the health, safety and safety, the administrative authority, after a formal notice to the Commune without effect, invites the Committee of Hygiene and Health to decide on the usefulness and nature of work deemed necessary. The Mayor is set to submit its observations to the Committee of Hygiene and Health. If the Committee of Hygiene and health issues an opinion in the performance of work or claims issued by the Municipality, the administrative authority shall send through official channels, the deliberations of the Committee of Hygiene and Health Minister of Health, if he thinks fit, refer the matter to the National Commission of Hygiene and Health. This can make or cause an investigation whose results are reported to the population by posting or any other means. Article 62. On the advice of the National Commission of Hygiene and Health, the concerned administrative authority shall Commune notice to implement the project and starting the work. If in the month following that notice, the City Council has not committed to bring there, or within three (3) months, he took no steps to execution the work, the competent authority under the powers available to it, these work orders right and determines the execution conditions. Article 63.- The general regulations of the police and hygiene constructions well as those concerning dangerous, unhealthy and troublesome are determined by decree of the Council of Government. However, laws and regulations in force governing such matters are apply, as appropriate, in all their provisions not contrary to the Code of Health.

21 Section 3 From the safety of rural Article 64.- In rural communities, it is for administrative and health authorities to ensure environmental sanitation and the basic infrastructure for drinking water, disposal of excreta and household waste. To protect the safety and health of the population, the authorities must ensure strict compliance with requirements for environmental health and habitat and suitability of food at all stages: production, processing, up for sale. More specifically and as part of the promotion of the fight against the deadly epidemic and contagious diseases, including the plague and cholera, setting up latrines and transport equipment, collection and disposal of waste, meeting hygiene standards required in villages and neighborhoods that lack them, subject to the requirements of Municipalities and Communities concerned. Article 65. In close cooperation with Fokontany located within the geographic boundaries of its territory, the municipality must strive to identify all the events giving rise to pollution which pose a danger to the safety and health of the population and to inform the administrative and health authorities concerned. This is particularly so of the existence of nuisance generated by industrial facilities, emissions of substances from discharges of industrial or craft facilities likely to harm public health, to alter the sources of drinking water or cause degradation of groundwater or that of the ambient air. CHAPTER IV

OF ENVIRONMENTAL PROTECTION Article 66. Pursuant to Article 10 of Law No. 90-033 of December 21, 1990 Environmental Charter and the provisions of Law No. ° 99-021 of August 19, 1999 on the policy of the management and control of industrial pollution, projects of public or private investment likely to harm the environment must be subject to an environmental impact Study . Article 67.- To ensure safety protection in the areas surrounding the facilities, installations, structures or works directly or indirectly relating to the administrative organization of medical and pharmaceutical services, ancillary texts in force related to Mise En Accounting for Investments with the Environment (MECIE) include a non-exhaustive list of works or works submitted as applicable to an Environmental impact Assessment (EIA) or Environmental Action Program (EERP). 1. are subject to an Environmental Impact Study: - the facilities, works and work likely, because of their technical nature, scope and sensitivity of the supporting environment have damaging environmental consequences ; - Any introduction of new species, animal or plant or Genetically Modified Organisms (GMOs) in the national territory; - Any processor or disposal of hospital waste; - Any type of storage products and / or radioactive waste 22

2. Are subject to an Environmental Commitment Program: - any unit of processing and storage of pharmaceutical products of more than 3 tons. Article 68.- The staff of hospitals: University Hospital, Hospital Regional Reference Centres, District Department of Health, Hospital District Centres, Health Centres Base and Hospitaller Establishments under the Sector private, need to be sensitized on the need to ensure, in the interests of health safety, the environmental cleanliness of facilities and infrastructure and, in particular, disinfection or destruction of objects used for the sick , monitoring and maintenance of irrigation canals or drainage, disposal of waste materials. TITLE II CONTROL BORDER HEALTH Article 69.- It is up to the Border Health Service at the entry points to prevent the international spread of disease while avoiding unnecessary interference with international traffic and trade . Travelers from, by air or sea from countries normally or accidentally infected or have been previously infected in the absence of provisions declaring that country again declare, relatively to their health status, classified under one of three regimes below: - Under brute license if they are or have been since their departure infected deemed a pestilential disease if they come from countries that are affected or have communicated with places , people or objects that could transmit their contagion; - Under the obvious suspect, if they come from countries where there is a disease suspected to be pestilential, or country, although qu'exempts illness, subject to such a suspicion are likely to be affected or finally, if due to communication from the above countries or in any other circumstances, their health status is suspect;

- Under the clean bill, so no suspicion of pestilence are in the country where they come from, if that country has not been or will not just be open relationship with places likely to be infected, and finally if no communication, no circumstances does suspect their health status. As necessary and based on the information obtained, the list of these sources should be a display at international airports of the National Territory.

Article 70.- Without prejudice to the International Health Regulations, the research carried out by officers of the health of Madagascar border control on passengers disembarking in order to detect whether an individual is carrying a sexually transmitted disease are prohibited under the right of individuals to privacy of their health.

23 Sanitary measures on arrival and departure can be undertaken: • examination on the destination, route and stay of travelers; • questioning about possible contacts; • verification of health documents at the vaccination certificate like, Maritime Declaration of Health, Aircraft General Declaration, Ship Sanitation Control Certificate. Article 71.- Without prejudice to the provisions of the International Health Regulations, except medical evacuation on Madagascar, the observation of a manifest disease state in a traveler entering Madagascar authorizes additional health measures such as a review medical monitoring by health services at the borders. Depending on circumstances, the Department of Health for Borders can: • require vaccination or other prophylaxis; • orient suspicious persons through the provision of advice; • placing suspected persons under observation; • quarantine suspicious persons; • isolation and treatment where necessary of affected persons; • refuse entry of suspect and affected persons; • refuse entry of unaffected persons to affected areas; • undergo screening people from affected areas and / or implement exit restrictions. Regarding baggage, cargo, containers, conveyances, goods and postal parcels, the Department of Health for Borders can: - refrain from advocating a specific sanitary measure; - Review manifest and routing; - Carry out inspections; - Review proof of measures on departure or in transit to eliminate infection or contamination; - Implement treatment of the baggage, cargo, containers, conveyances, goods, postal parcels, corpses or human remains to remove infection or contamination, including vectors and reservoirs; - Use of specific health measures to ensure the safe handling and transport of human remains or human remains;

24 - implement isolation and quarantine; - Require, in the absence of effective treatment or process, seizure and destruction in baggage, cargo, containers, conveyances, goods and postal parcels infected, contaminated or suspected; - Refuse departure or entry of any traveler and / or suspicious goods. BOOK II OCCUPATIONAL MEDICAL, PARAMEDICAL AND TRADITIONAL MEDICINE TITLE ONE MEDICAL PROFESSION, TO ACUPUNCTURIST (TRICE)

On ODONTO-stomatologiste, MIDWIFERY Article 72.- No person may practice the profession of physician acupuncturist (trice) of odonto oral surgeon and midwife if it is nationality Malagasy, holder of diplomas or certificates recognized by the Malagasy State and registered in the Roll of the Order concerned. Qualifications required for the performance of each of these professions are defined and established by Decree of the Council of the Government on the proposal of the Minister of Health. This table is filed in the Ministry of Health and the Public Prosecutor at the Court of Appeal. In the month of January each year, it is published in the Official Gazette of the Republic of Madagascar. Article 72 bis.-however, may practice as a physician acupuncturist (trice) Odonto-oral surgeon and midwife, without prejudice to the foregoing provisions: - Military doctors, military odonto- dentists belonging to the Malagasy Armed Forces ; - Doctors, practitioners who received acupuncture training, odonto- dentists or midwives accredited foreign missions, subject to the conditions imposed by the regulations in the matter and after consulting the Board the corresponding National Order; - Doctors, practitioners who received acupuncture training, odonto- dentists or midwives national of a country bound by a reciprocal agreement with Madagascar, subject to obtaining an individual authorization exercise issued by the Order concerned and, if necessary, renewable every two years. Article 73.- The moral and professional duties of members of the medical and paramedical professions are defined in the codes of ethics established by the relevant orders. The provisions of those codes are set by each interested Order form of Decree of the Council of the Government on the proposal of the Minister of Health.

25 Article 74.- The paramedical professions are those, relating to health, are held outside of routine care on demand, under supervision of a physician. Article 75.- A member from the Medical Corps, paramedics and other health worker without exception, entitled to exercise his art, is bound to comply with requisitions legally issued by the public authority to perform acts related his Speciality. In this case, interventions give the right to compensation under the provisions of the Right to Organise and paid for by the requesting authority. Article 76. Patients employees in a company are free to consult practitioners of their choice, unless the company is bound by an exclusive contract with health agencies licensed by the state. Article 77.- The midwives are allowed: - to act as a paramedic and implement their professional competence as it was acquired at the end of the training established and recognized by the State Malagasy; - To perform prescribed or recommended by a physician care benefits; - To prescribe medication and additional examinations jointly authorized by the National College of Midwives and the National Order of Physicians and the prior approval of the Minister of Health. Article 78.- The conditions and rules of exercise of the profession of doctor, acupuncturist, Odonto-oral surgeon, midwife and, if applicable, those of realizing other medical professions and paramedical are established by Decree of the Council of the Government on the proposal of the Minister of Health. CHAPTER I ILLEGAL EXERCISE MEDICINE AND ACUPUNCTURE

Article 79.- Exercise illegally medicine and art of acupuncture: 1. any person - which usually takes or direction followed, even in the presence of a doctor at the institution a diagnosis, prescription drugs or other treatments of diseases or surgical conditions, congenital or acquired, real or imagined, by personal act, verbal or written consultation or such other means whatsoever; - Who practice one of the professional acts described in a schedule set by decree of the Minister of Health, without diploma holder of State or University of MD, or any graduate whose 'level of equity and value is recognized by the Malagasy State;

26 - no doctor or physician not provided with a certificate or a diploma in acupuncture delivered by an internationally recognized Institute or University and recognized by the Malagasy State; - Pledged a license to practice acupuncture but does not meet the conditions and rules for exercising this discipline, including the provisions of Article 91 of this Code; 2. any person who provided a regular basis, is outside the remit that the law confers, particularly in providing assistance to persons mentioned in the preceding paragraph, to the effect of exempting the requirements of this chapter; 3 . any doctor or physician practicing medicine without being registered on the Roll of the Order of Doctors established in accordance with this Code, or exercising in fraud during the period of temporary or permanent suspension under Article 91 of this Code. There are no illegal practice of medicine if support paid to a person in danger, subject to the conditions specified in Article 63 of the Penal Code. Article 80.- The provisions of the previous article do not apply to students in medicine, acupuncture or midwives or nurses or patients guards who act as with a medical doctor that the latter premises of his patients, to the extent that these students, these midwives, nurses or these these nurses act in strict compliance with the requirements of the doctor concerned. They do not apply to medical aids and other practitioners with a special authorization from the health authority. An order made by the Minister of Health sets the extent of their competence. CHAPTER II EXERCISE OF ILLEGAL ODONTO-STOMATOLOGIE Article 81.- Exercise illegally Art odontostomatology: 1- any person who, without holding a state diploma or University doctor odontostomatology recognized by the Malagasy State takes usually by hand or direction followed in the diagnosis and treatment of congenital oral diseases acquired real or perceived, for consultation, personal act or any other process whatsoever, including prophetic; 2- all odonto- stomatologiste that, with a regular title, is outside the remit that the law confers, particularly through all persons mentioned in the preceding paragraphs of this article to the effect of exempting the requirements of this chapter; 3- odonto- stomatologiste any private, corporate, religious, civil servant who exercises the odontostomatology art without being registered on the Roll of the Order of dentists odonto without being in order vis-à-vis the College Council or exercising in fraud during the period of temporary or permanent suspension under Article 91 of this Code.

1- anyone not equipped with the degree from a school recognized by the Malagasy State, usually practice the functions of midwives by usurpation of titles planned act and punishable under article 258 of the Penal Code ; 2- any midwife who usually practice this profession in the national territory, without being of Malagasy nationality or being a member of the foreign missions accredited or national of a country bound by a reciprocal agreement with Madagascar, and without prejudice provisions contained in international or taken in execution of these agreements agreements; 3-any midwife who usually practice this profession without the Roll of the Order of Midwives established by this Code or exercising in fraud during the period of temporary suspension or permanent exercise under Article 91 of this Code. However, the provisions of this paragraph shall not apply to female military personnel midwives Malagasy Armed Forces; 4- any midwife convicted of making a false statement during the recording of his degree and / or during registration on the Roll of the Order, and without prejudice to the penal provisions that sanction the violation arising false statement; 5- any midwife in private practice and who failed to comply, in the month following its establishment obligations to register his diploma to the Ministry of Health and the National Order of Midwives. Are not affected by the provisions of this Article the traditional birth attendants who perform their duties within the limits of their jurisdiction enacted by this Code. Article 83.- The disciplinary punishments and penalties pursuant to Articles 79 to 82 are provided for in Book IX of the Code. CHAPTER IV NATIONAL ORDERS Article 84.- The right to institute a National Order is recognized in every medical and paramedical profession whose members, because of their inclusion in the Roll of the Order are entitled to practice their art. The National Order may well established, as necessary, be extended in the regions under the name Regional Council by decision of the Order in Council decision concerned the General Assembly of the National Order. No one can be enrolled in these orders if it is Malagasy nationality or national of a country bound by a reciprocal agreement with Madagascar. The development of the internal regulations of each Order, the mission of the Order, the role and composition of the different Councils, terms of elections and any specific provisions in each order are determined by order of the Minister of Health. 28

Article 85.- Registration for the Roll of the Order corresponding Makes lawful exercise of the medical profession, odonto- oral surgeon, midwife or pharmacist about all the national territory. It is the same for nurses and other health professionals in case of establishment of a National Order for the Corps. At the date of implementation of this Code, the provisions of the preceding paragraph also apply to any staff member of the medical and paramedical body without taking into account whether or not a paying customer . Article 86.- A member of the medical corps and paramedical employees serving the public authority, as well as the official medical staff that the official teaching staff engaged permanently or for a fixed term or as part of a mission and any member of the medical and paramedical body of a company, a faith-based organization, a community, a non-governmental organization or an institution of private law, full-time employee must have a license to practice private or paying customers, issued by the Ministry of Health, before opening a private firm in his name. However, it allowed to receive in his private cabinet employee to his home administration or the estate of the employee, unless that clause is expressly stipulated in his employment contract. Article 87.- The civil servants, members of the Medical Corps and allied Corps, who want to make the privately paying clients should refrain from using the goods and materials of the state made available for the operation of public services. Violation of the provisions of this paragraph constitutes unfair competition crime and embezzlement of public funds involving the application of penalties in force in the matter. PART II SOME SPECIAL RULES Article 88.- The provisions of this Title shall apply: - the members of the Medical Corps; - Members of paramedical Corps; - Physician assistants; - Traditional healers. Article 89.- Any member of the Medical Corps, Corps of paramedics, medical auxiliaries and healers must comply with the following requirements: 1 is prohibited to conduct a Voluntary Interruption of Pregnancy or favor abortion under pain of the sanctions provided by Article 317 of the Criminal Code, except as prescribed by laws and regulations; 2 in particular, is liable to the penalties provided for in Article 160 of the Penal any member of the Body Code paramedics who issues a medical certificate, medical complacent conclusions on a condition for: a . to provide a person of a public service obligation legally due or avoid stress under the law as including a measure of custody or a judicial inquiry;

29 b. to prevent a person sentenced to imprisonment or detention constraints of a stay in a prison in the making admit, without duly justified reasons, in a hospital or a health facility outside prison ; c. harm to either party in a lawsuit without any need to establish the existence of an act of corruption. 3- addition to the above prohibitions on the exercise of the profession of doctor, paramedics, paramedics and traditional healers, are prohibited:

- Any direct or indirect form of promotion campaign publicizing medical specialties or instruments and equipment that we have and which may, by their newness and unusual to attract customers; - Any direct or indirect form of advertising to encourage the attendance of customers. The transgression of the prohibitions listed above is subject to the penalties provided in the material under Book IX of this Code. Article 90.- A member of the medical and paramedical Corps in the exercise of the profession, can be prosecuted homicide, intentional assault under articles 319 and 320 of the Penal Code. Article 91.- In the case of disability or medical condition of a member of the medical corps or paramedics Corps, making dangerous exercise of the profession, the Council of the Order to which it belongs can pronounce for it, the temporary suspension for a fixed but renewable term of license to practice. The final suspension or denial of the right to exercise may be imposed in case of confirmation of a health professional alienation of state. Nevertheless, the temporary or permanent suspension of the right to exercise can be declared only on reasoned report prepared by two (2) experts of which is chosen by the person concerned or his family and the other appointed by the Council of order concerned. The report prepared by these experts should be sent within a maximum of two (2 months in the Council of Order concerned that transmits to the Minister of Health's decision. In case of failure of the person concerned or his family the choice of the expert, the employer Service, at the request of the Council of the Order concerned, must choose one.

PART III oF tHE PROFESSION oF NURSING (E), OTHER AUXILIARY MEDICAL aND TRADITIONAL HEALTH PRACTITIONERS Article 92. East regarded as exercising masseur physiotherapist persons who have received adequate training and a diploma recognized by the state and regulated by Decree of the Council of Government on the proposal of the Minister of Health. 30

The physiotherapy masseur aims to carry out acts of manual or instrumental to re-education purposes, for the purpose of preventing impairment of functional capacity, to contribute to their maintenance and when altered, restore or 'supply it. In the exercise of its activity, the physical therapist must consider the psychological and cultural characteristics of each patient, to respect his personality and to refrain from any action likely to undermine the patient's limb. Exercises illegally masseur physiotherapist anyone, not equipped with the diploma required for this purpose usually practice acts vested in physiotherapist and appropriating the title. Article 93.- is considered as exercising the profession of nursing (e) any person holding a nursing diploma (e) issued by a nursing school (e) recognized by the Malagasy State. The practice of nursing (e) in the absence of the aforementioned degree is illegal and liable to the penalties provided for in Article 335 of this Code. These same penalties incurred in the event of illegal practice of the nursing profession (e) during the period of temporary or permanent disqualification as provided in Article 91 of this Code. The nurses (es) with a diploma of Medical Assistance exercise the nursing profession (e) until the expiry of the frame to which they belong. The conditions and rules of exercise of the profession of nursing (e) are fixed by decree of the Council of the Government on the proposal of the Minister of Health. Article 94.- The conditions and rules of practice of the profession of technicians in orthopedics pedicure of optician, are regulated by decree of the Council of the Government on the proposal of the Minister of Health. Article 95.- The exercise of Traditional Medicine is legally authorized and recognized, to any natural or legal person, individually or in combination, in the conditions determined by the provisions of this Code. Traditional practitioners engaged in the treatment of patients as part of traditional medicine can exercise according to local laws and regulations. But in any case, they can make a diagnosis by use of slang terminology or allopathic medicine, homeopathy and osteopathy or manipulate prepared or classified chemicals "pharmaceutical" and outside the traditional pharmacopoeia, prescribe any drug product or pharmaceutical specialties within the competence of pharmacists. Article 96.- Under the terms of this Code is meant by: Traditional Medicine: the sum total of all knowledge and practices used in diagnosis, prevention and elimination of physical imbalances, mental and social process based solely on practical experiences and passed down from generation to generation observations orally or in writing, to prevent, cure diseases and alleviate suffering.

31 -Tradipraticien Health: anyone who practices Traditional Medicine as defined and the principles set out above. The traditional healer can be: a • Traditional birth: a term for anyone found to be competent to provide a woman and her newborn, before, during and after delivery based health care on concepts prevailing in the community where she lives;

• one or a traditional therapist: a term for any person recognized by the community in which she lives as competent to provide health care based on the concepts of disease and disability prevailing in the said community. These Traditional Healers are designated by different names depending on the region. A full list and details will be made by Enforcement Decree of the Act; • one or Herbalist: a term for anyone selling medicinal plants; • one or a Medical-druggist: a term for anyone who sells medicinal substances other than plants (animal or mineral origin). Article 97.- The practice of HOMEOPATHIE and OSTEOPATHIE, individually or in combination, is legally permitted and recognized in Madagascar by the provisions of this Code. Article 98.- Under the terms of this Code is meant by: - Homeopath: a physician who received training in homeopathy, original processing method developed by Hahnemann in 1970 and based on the pharmacological principle the inversion of the infinitesimal dose-effect or law of similars. In essence, homeopathic techniques enable a holistic and individualized therapeutic approach. - Osteopath any person having received training in osteopathy, manual therapy method developed in 1874 by Andrew T. STILL drawing on his own observations and his knowledge of anatomy. New elements in the development of osteopathy were made later by Sutherland (1873-1954) and John UPPLEDGER (1983). Osteopathy uses two hands to handle. Article 99.- The conditions and rules of exercise of the profession of homeopathy and osteopathy are governed by the internal status of Homeopaths Without Borders Association in Madagascar after approval of the Minister of Health. Article 100.- The recognition as traditional health practitioner is acquired by decision from the Ministry of Health on a proposal of the National Council of Traditional Medicine.

32 The establishment, organization and operating procedures of the National Council of Traditional Medicine are established by Decree of the Council of the Government on the proposal of the Minister of Health. The National Council is responsible, among other things, control and monitoring of the exercise of Traditional Medicine, as part of its promotion and development. As necessary, a communal antenna of the National Council may be established in each Commune, under the name of "Communal Advisory Committee" responsible for the oversight and monitoring of the practice of medicine in the concerned commune. Traditional healers are allowed to be in charge of ensuring the Association the promotion and development of Traditional Medicine, provided that it is officially recognized as a public utility. Documents, objects and remedies used in Traditional Medicine must be presented: - at the request of health or administrative authorities exercise areas; - Any control ordered by the Minister of Health or the National Council of Traditional Medicine. Article 101.- No person may practice the profession of traditional healer, in the national territory, if it is not: - Malagasy nationality; - Resident in Madagascar; - Authorized by the Minister of Health and registered in the local and national records of the Association;

- Recognized good character and enjoy his civil and civic rights for a period of 5 years preceding the date of registration in the register; the loss of those rights automatically entails deletion from the register; - Twenty-one (21) years of age. Article 102.- In the exercise of their functions, traditional healers are not allowed, nor to make judgments about the effectiveness or otherwise of the methods of modern medicine and those officially authorized in the national territory, or to encourage desert the public and private health facilities. The provisions of Articles 75, 90 and 91 of this Code shall apply to auxiliary medical and traditional healers. A decree of the Council of Government on the proposal of the Minister of Health sets conditions of exercise, organization and operation of traditional medicine.

33 BOOK III DRUGS, PHARMACY AND CONDITIONS OF PRACTICE PHARMACIST Article 103.- The Code applies to any person practicing the profession of pharmacist in activities within the field of medicines and other health goods and the sale of medicinal plants on the territory of the Republic of Madagascar. TITLE I DRUGS AND PHARMACY CHAPTER OF THE NATIONAL PHARMACEUTICAL POLICY Article 104.- The National Pharmaceutical Policy is part of the National Health Policy defined by the Government. It aims to ensure adequate supplies of essential medicines of good quality, safe, effective and rational use of these drugs. In order to ensure sufficient and sustainable supply of essential medicines of good quality, safe and effective, the National Pharmaceutical Policy should focus on promoting research and the national pharmaceuticals production. The Malagasy pharmacopoeia must adopt standards that support this goal of national production. The Medicines Agency of Madagascar, which reports directly to the Ministry of Health, is the body responsible for population control and the activities of pharmaceutical companies, their inspection, registration of medicinal products for human and other similar products, drug quality control, pharmacovigilance in the national territory. CHAPTER II

OF DRUGS Section 1 Definitions Article 105.- The term drug any substance, preparation or composition presented as having curative or preventive properties in respect of human and animal diseases and any product that can be administered to humans or animals in order to making a medical diagnosis or to restoring, correcting or modifying organic functions. Are considered as drugs: - cosmetics and personal hygiene products containing a substance having a therapeutic action in the sense of paragraph 1 or containing poisonous substances in doses or concentrations than listed under order of the Minister of Health or not on that list;

34 - diet products that contain in their composition of chemical or biological substances not constituting themselves food, but whose presence may confer on these products, or special properties desired therapeutic dietetics or the test meal properties;

- Immunobiological products used to prevent, diagnose or treat human diseases that affect the immune system or may be involved in immune biological reactions such as vaccines, allergens, toxins and antitoxins, sera, immunoglobulins; - Products presented as suppressing the urge to smoke or reducing tobacco addiction; - Oral, injectables, implants, spermicides whose dispensation is allowed by the Medicines Agency of Madagascar. Article 106.- Except when a new drug has already presented and recognized as such by the World Health Organization (WHO), a new drug product is classified discovered or invented in Madagascar on validation by an Institution biomedical recognized by the Malagasy State. This institution certifies the nature of the product, the research protocol, the active ingredient identified and the selection mode, the therapeutic virtue, side effects, contraindications, and the degree of risk of toxicity. The introduction of new contraceptive products will be subject to a decree of the Minister of Health on the advice of a committee formed by health professionals in the public and private sector. Before turning to public provisions, the product must be registered with the Medicines Agency of Madagascar to the Ministry of Health. Article 107.- Human blood and blood products are not considered drugs but are subject to special provisions regarding their collection or their preparation, their use, control, storage condition and their dispensation. Activities related to these products are subject to inspection by inspectors pharmaciens- under the Medicines Agency of Madagascar or by other qualified agents and authorized by the Ministry of Health. Article 108.- The Pharmacopoeia is a collection of standards designed to ensure uniformity of kind, quality, composition and concentration of drugs and other pharmaceutical products. It is the reference manual for pharmacists for the manufacture and control of drugs and for officinalis and compounding. The development of a properly Malagasy pharmacopoeia succession of joint work Ministry of Scientific Research and the Ministry of Health in establishing common standards of locally manufactured medicines while using this 35 effect potentials and as human, natural and financial and technical that exist in Madagascar. Provisionally, the European, British Pharmacopoeia, US Pharmacopeia or other useful recognized pharmacopoeia are admitted by decree. Article 109.- The traditional Malagasy pharmacopoeia gathers information on plants and other natural products that can be used in human therapy and codifies the preparation and use of pharmaceutical drugs that they produce. The Commission Malagasy traditional medicine, whose organization and functioning are established by decree of the Council of Government, is under the authority of the Ministry of Health. Article 110.- Definitions:

Generic -médicament, any medication prepared in advance, marketed under an international name, the active ingredient or ingredients are not or are not protected by a patent. Its composition and dosage form are identical to those of the innovative specialty, concentration of active ingredients are identical to those of the innovative specialty, concentration of active ingredients is the same and as wide therapeutic range; bioequivalence with the reference product was demonstrated. All generic characterized by a special name is called "generic brand"; -médicament essentially any drug that meets the needs of the majority of the population in terms of health care; -preparation masterful, any drug extemporaneously prepared in a pharmacy or a health facility pursuant to a prescription for an individual patient; -preparation hospital, any drug on prescription and prepared according to the indications of the pharmacopoeia because of the lack of available or suitable pharmaceutical specialty in internal use in the pharmacy of a health facility and to be delivered to one or more patients in the said establishment; -preparation officinale, any drug prepared in pharmacy according to indications of pharmacopoeia or a form recognized by the Malagasy State and intended to be delivered directly to the patients served by the pharmacy; -produced divided pharmacies, substance or any stable preparation described by the pharmacopoeia, prepared in advance by a pharmaceutical company and divided either by him or by the community pharmacy which sells, or by use pharmacy internal; pharmaceutical -Specialty, any medication prepared in advance, presented in a special pack, characterized by a special name and marketed under that name; -médicament homeopathic any medicinal product prepared from products, substances or composition called homeopathic stocks, in a process of 36

homeopathic manufacturing described by any pharmacopoeia recognized in Madagascar. A homeopathic medicinal product may also contain several active ingredients; -remède secret, any preparation which the formula is not on the drug itself, or in a pharmacopoeia or in a form, or the scheduler of pharmacy. Selling secret remedy is prohibited; -consommables medical, product, and other equipment used to perform medical procedures. Section 2 Official lists of drugs Article 111.- In the interest of public health and pursuant to the National Pharmaceutical Policy, the various formularies allowed to be provided to the public shall be established and amended by the Minister of Health, on the advice of a commission formed by health professionals in the public and private sector. The composition of this commission will be defined by decree of the Council of the Government on the proposal of the Minister of Health. The Minister of Health stop: - the national list of essential medicines; - The list of generic substitution; - The list of narcotics, psychotropic substances and precursors subject to international control ; - The list of banned substances, poisonous, toxic, and others; - The list of drugs whose unpacking and repacking are allowed; - The list of authorized medicines to be prescribed for each category of prescriber; - The list of authorized medicines to be given to the public by the various dispensation structures; - The list of colorings, preservatives and additives necessary for agents

Manufacture of medicines; - The list of medicinal plants allowed to be used in human medicine; - The list of medicinal plants prohibited to human medicine; - The list of prohibited medical consumables to human medicine; - The list of medical consumables subject to Authorisation on Market (AMM); - The list of drugs authorized for advertising. Article 112.- The national drug formulary or compendium is the synthetic collection of scientific and technical information relating to medicinal products and generic medicines on the essential drug list registered in Madagascar and classified by international nonproprietary name.

37 Section 3 The herbal medicines and traditional medicines Article 113.- Definitions: - Herbal drug, any drug containing as active ingredient exclusively plant products or substances from plants or plant preparations; - Herbal preparation, the powdered plants, juices, extracts, tinctures, fatty oils, and any preparation which involves the use of methods of concentration, fractionation or purification and used as drug ; - "Traditional" remedy, any plant material, animal or mineral presented as promoting the prevention or treatment of human diseases and traditionally used on the socio-cultural foundations and / or religious. It is not intended to be injected parenterally. He is reserved and controlled use. Article 114.- is considered "traditional remedy improved" all traditional remedy having undergone changes in order to increase acceptability. All non-original substances added, such as excipients, or practice contributing to the improvement of traditional medicine should be indicated. The herbal medicines, herbal preparations and improved traditional remedies are subject to the provisions of this Code governing the manufacture, sale, distribution, sale to the public, advertising and drug promotion . Improved traditional remedies must meet national ethical standards, technical standards Malagasy Pharmacopoeia or other pharmacopoeia recognized by the Malagasy State. The provisions governing the preparation, registration, distribution and sale to the public traditional medicines and other products used in traditional medicine, will be specified by regulation.

CHAPTER III OF THE GENERAL RULES CONCERNING DRUGS Section 1 From check Article 115.- Any medicine for human use or assimilated product, manufactured locally or imported, is subject, before marketing or her dispensation, even for free, to a Authorisation Market (AMM) issued by the agency Medicines Madagascar, after investigation of a file and a decision of a National Commission for Drug Registration. Nevertheless, a Temporary Authorization to Sell or ATV may be issued by the Minister of Health to essential medicines in the public health requirements but whose frequency does not justify an application for marketing authorization. The criteria for obtaining this derogation are set by order of the Minister of Health.

38 The Authorisation Market is issued for a drug whose

Name, composition, dosage form, route of administration, dosage, therapeutic indications, packaging, shelf life, labeling, mode of delivery and the wholesale price excluding tax are defined, and for which a registration number is assigned. Any change to any of these features, except the price, must be subject to a new authorization. The Authorisation Market is issued only a drug whose effectiveness, therapeutic, safety under normal conditions of use and the intrinsic quality are documented and proven or known. Any modification of the excipients, the manufacturing process or place of manufacture should be reported to the Drug Agency of Madagascar. Sale of medical consumables, the list is fixed by decree of the Minister of Health, is subject to the granting of permission to the Marketing issued by the Medicines Agency of Madagascar. Registration procedures will be specified by order of the Minister of Health. Demand for Development of the Marketing Authorisation should be addressed to the Director of the Medicines Agency of Madagascar, accompanied by the payment of a fixed fee, the amount is determined by joint order of the Minister of Health and Minister of Finance and Budget. The terms and the elements of the dossier submitted to are specified in the regulations. Article 116.- The decision granting or refusing to grant permission to the Marketing is taken within a maximum period of four (04) months from the filing of the application by the Director of the Agency of Medicines Madagascar, after consulting the National Commission for Drug Registration whose composition and functioning are established by decision of the Minister of Health. The Director of the Medicines Agency of Madagascar has the opportunity to appeal to independent experts chosen according to the product presented to the National Commission for Drug Registration. Refusal to Authorisation Market must be a reasoned decision. As necessary, the conditions for granting or withdrawing Authorisation for medicinal Market or other similar income will be subject to regulatory texts. The Authorisation Market is issued for a period of five years renewable for five-year period at the request of the authorization holder, three (3) months before the expiry date of the previous authorization, if takes place. Article 117.- The holder of the authorization of the Marketing must respect the rules on labeling, packaging and the information leaflet label issued by the Medicines Agency of Madagascar. 39

No Authorisation Market will be given to a drug whose consumption or sale was banned and has been withdrawn from the market abroad. The Agency Madagascar Drug publish a list of authorized medicines to be placed on the market in the territory of Madagascar, and the list of drugs withdrawn from the market. It also maintains and publishes the list of pharmaceutical companies and other drug delivery institutions authorized to carry. Article 118.- are not subject to the authorization of the Marketing official formula, compounding and preparations for the conduct of clinical trials. Article 119.- The Director of Madagascar Drug Agency may, by reasoned decision, after consulting the National Commission for Drug Registration, suspend or withdraw the Authorisation of a drug market that s' proved harmful in the normal conditions of employment or whose therapeutic efficacy is lacking or that the qualitative or quantitative composition does not match that which has been declared. It is the same when the information submitted during the application for leave are wrong, as provided for by the regulation are not met, or changes affecting the quality of a drug or compliance with required specifications were found during an inspection. In the cases mentioned above, the holder of the authorization of the Marketing is obliged to procure the registration, and pharmacists, wholesale distributors, manufacturers must take all necessary measures to the immediate cessation of the issuance to the public of said drugs. If these provisions are not included in the time compatible with the protection of health of the population of Madagascar Medicines Agency shall take all appropriate measures. Article 120.- Any medication dispensed to Madagascar and removed from the market of a country for public health reasons may be the subject of a reasoned and notified withdrawal by decision of the Medicines Agency of Madagascar. Article 121.- The import of drugs, as part of the international emergency aid is exceptionally authorized in the territory of Madagascar, provided that these drugs are accompanied by a 'Authorisation on the market in valid country or from Madagascar or a certificate within the certification system of the quality of the World Health Organization, or else import authorization issued by the Agency drug Madagascar. A decree of the Council of the Government on the proposal of the Minister of Health whose provisions must comply with international conventions, fixed regulation of drug donations. Section 2 Clinical trials Article 122.- by clinical trial is a drug, any research or experimentation conducted to: 40

Every clinical trial must be conducted in strict accordance with the study protocol, the objectives and methodology are clearly defined and that has been reviewed and approved by a committee established for that purpose by order of the Minister of Health: the Committee Ethics from the Ministry of Health on biomedical research involving human beings. The composition, appointment of members, powers and functioning of the Ethics Committee to the Minister for Health will be fixed by order of the Minister of Health. Every clinical trial must be subject to prior authorization of the Minister for Health after consultation with the Ethics Committee. Clinical trials on the National Territory must be carried out according to the principles and guidelines of Good Clinical Practice of the World Health Organization, in accordance with the principles contained in the Helsinki Declaration and the Handbook for members Ethics Committee at the Ministry of Health. Unauthorized clinical trial, or strictly not respect does the study protocol approved by the Ethics Committee at the Ministry of Health, in accordance with the principles contained in the Helsinki Declaration and the use Guide members of the Ethics Committee at the Ministry of Health, is classified as dangerous in obvious risk experience and engages the civil and criminal liability of its author. Section 3 Pharmacovigilance Article 123.- A "pharmacovigilance" the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other problem related to drugs or health products on the market, consideration or not, this risk is proven potential. It also includes all the centralization of operations, monitoring and dissemination of information on adverse drug reactions. Article 124.- The granting of a Marketing Authorisation on the market for a drug submits the holder the obligation to inform the Agency of Medicines of Madagascar of any "unexpected adverse reaction" brought to its attention. This obligation applies to prescribers, providers and beneficiaries. The manufacturer of a licensed product or importer must inform the Agency of Madagascar Drug withdrawal or suspension of the product in the country of origin as soon as it has knowledge.

41 Section 4 The prescription Article 125.- are allowed to prescribe: - the doctors ; - Internal and external hospitals; - Internal medical trainees under the authority of the doctor responsible service; - Dentists within a list determined by decree of Minister of Health; - In the absence of medical, paramedical within the limits of authorized drug lists for each level of health facility. On any order must include the name, academic title, specialty and address of the prescriber, the registration number to the Order if the Order is established, the name, age, weight and address of the patient for whom the drug is prescribed, the name or the international name of the prescribed drug or formula of compounding, dosage and duration of treatment, date, stamp and signature of the prescriber. Except as provided in the regulations, it is forbidden for any specifier

Medicines and other pharmaceutical products to receive any form whatsoever, directly or indirectly, any interest or dividends proportional or not to the number of units sold. Section 5 From preparing Article 126.- The only persons authorized to prepare medicines and other pharmaceutical products: - community pharmacists; - Pharmacy technicians under the supervision of a pharmacist; - Pharmacists different public and private hospitals; - In public health facilities, paramedics in limited lists of authorized pharmaceuticals. Section 6 From the dispensation Article 127.- The term dispensation distribution to the public or patients to medicines and other health goods, complemented by information and advice necessary for their proper use. Any issue against payment or free of pharmaceuticals outside the pharmaceutical and health establishments is prohibited. Drugs and expired products should be withdrawn from use. A pharmacist, who is accused of selling expired products, with respect to this charge shall be brought before the Council of the Order for violation of laws and regulations on pharmaceuticals. The sanctions provided for in the provisions of laws and regulations in force on food fraud and abuse vis-à-vis consumer confidence also apply to it.

42 Article 128.- The conditions of storage and conservation of medicines indicated by the manufacturer must be respected. Medicinal products authorized to be placed on the market, except those whose deconditioning is authorized and are registered on the list referred to in Article 111 must be issued in their original packaging, for which they received approval of the Marketing. Pharmacists can not change a prescription with the express agreement of the author. However, the pharmacist is authorized to advise the substitution of a drug by its generic equivalent of cost, on the list established by the Minister of Health. Section 7 De pricing Article 129.- The Pharmacists Inspectors under the Madagascar Drug Agency are responsible for controlling and enforcing the tariff regulations in all public and private pharmaceutical establishments as well as in drug depots. Section 8 Promotion and advertising A. Promotion Article 130.- promotion is any action by laboratories and distributors to prescribers and other health personnel duly authorized to practice in order to make their products. No promotion may be made for a drug before Authorisation the Marketing has been granted by the Drug Agency of Madagascar said medicinal product. Are not affected by this provision the information in the context of conferences and publications in scientific. Article 131.- The pharmaceutical companies can use medical delegates or visitors to promote their products. They are required to make registration with the Medicines Agency of Madagascar. The regulations specify, as regards delegates or visitors Medical: - the level of payable minimum qualification; - The administrative requirements to be met; - The responsibilities of the employer. Article 132.- The presentation of the pharmaceutical product to prescribers and other

Health professionals should be made objectively, in the interest of public health and comply with the instructions for use and issuance approved in the context of the Authorisation on the Market. All information contained in the documentation given to professionals health must be accurate, current, verifiable and sufficiently complete to enable the recipient

43 to her own opinion of the therapeutic value of the drug and use. They are subject to the issuance of a visa by the advertising Medicines Agency Madagascar. Article 133.- The medical samples should be identical to the smallest packaging marketed and be marked 'free medical sample ". It is forbidden to sell medical samples. Medical samples of drugs on the lists I and II of poisonous substances can be released only empowered health workers to prescribe and, upon written request, signed and dated by the applicant. In any case, drugs may be issued by way of medical samples. Direct distribution to the public of medical samples for promotional purposes is prohibited . Article 134.- In the promotional framework to persons qualified to prescribe or supply medicinal , it is prohibited to grant, offer or promise any direct or indirect material benefits in kind or in cash . B. Article 135.- advertising advertising refers to medicinal products for human use any form of information, canvassing activity or inducement other than that relating to the promotion, which aims to promote the prescription, supply, sale or drug consumption by the public. Article 136.- The application of the regulation and supervision of advertising is provided by the National Commission of the Pharmaceutical Advertising Control. Article 137.- The advertising must not be misleading or prejudice the protection of public health. It must submit the drug or objectively product and promote its proper use. Advertising to the public for a drug is permitted only if the drug has obtained the authorization of the Marketing and it is not subject to medical prescription. Advertising to the public for a drug must be accompanied by a message of caution and return to consulting a doctor if symptoms persist. Advertising to the public for a drug determined and advertising campaigns to the public for vaccinations are subject to prior authorization of limited duration referred Advertising visa issued by the Medicines Agency of Madagascar. It comes with a fixed fee, the amount is determined by joint order of the Minister of Health and Minister for Finance and Budget. This visa is issued for a period not exceeding the duration of the Authorisation on the Market. The conditions for granting, suspension or withdrawal of advertising visa are defined by decree of the Minister of Health.

44 CHAPTER IV

OF DRUGS, PSYCHOTROPIC AND PRECURSORS Article 138.- The Ministry of Health and the medical and paramedical staff under his authority, the professions of Health under the Private Sector, pharmacists involved in the implementation of the law n ° 97-039 from 04 November 1997 on the control of narcotics, psychotropic substances and precursors in Madagascar as well as setting the implementation of National Master Plan for the Fight against drugs and related criminal activities. Article 139.- per narcotic means, any plant or substance of natural or synthetic origin, sedative, analgesic, narcotic or euphoric may cause habituation, addiction or dependence. The drugs under the control shown in Tables I and II of the Single Convention on Narcotic Drugs Geneva 1961, amended by the Protocol of March 1972. Article 140.- It is considered psychotropic substances "all original chemical substances natural or artificial, which have a psychological tropism, that is to say capable of modifying mental activity without prejudice to the type of this change. " Are subject to control psychotropic substances classified according to their potential for dependence and degree of therapeutic utility in Tables I, II, III and IV of the Vienna Convention on Psychotropic Substances of 21 February 1971. Article 141. - the term precursor substances used for the manufacture of narcotic drugs or psychotropic substances. The precursors subject to control are shown in Tables I and II of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988. Article 142.- The definitions are extended to any modification of tables that may be taken subsequently by decision the United Nations drug Commission. Article 143.- The Minister of Health is responsible for the national implementation of international conventions signed and ratified by the Republic of Madagascar, in the pharmaceutical sector, the drug and the inspection of establishments. Article 144.- In application of the international conventions on narcotics control and psychotropic substances ratified by the Republic of Madagascar, the production, manufacture, transport, import, export, possession, supply, transfer, acquisition, distribution and use of poisonous substances or plants classified as psychotropic or narcotic as are subject to special authorization, renewable and limited exclusively to medical and scientific purposes. The conditions for granting of any authorization are laid down by regulation. Article 145.- The authorized drugs can be issued only on special prescription taken from a counterfoil. Authorized psychotropic can only be issued on prescription.

45 The conditions of prescription and supply of such preparations are laid down by regulation after consultation with the National Councils of the Order of Physicians and the Order of Pharmacists. CHAPTER V PARAPHARAMACIE AND OTHER HEALTH PROPERTIES section 1

The cosmetics and personal care Article 146.- The term cosmetics and toiletries, all substances or preparations, other than medicines, intended to be placed in contact with the various external parts of the body human, teeth or mucous membranes, to clean, protect, maintain them in good condition, changing their appearance, the flavor or to correct the odor. All cosmetics and personal hygiene without well-defined therapeutic purposes should not include in its name such words as: HEALTH; MEDI; MEDICAL PHARMA ... or that could mislead the public. Article 147.- Sale of cosmetics and personal hygiene is not exclusively for pharmaceutical establishments. The conditions for opening and operating of any manufacturer establishment, conditioning or even significant ancillary cosmetics or personal care products, as well as the extension of the activities of an establishment of such products are laid down by regulation. Article 148.- Any cosmetic or personal care product should, before being put on the market, for payment or free of charge, subject to an application for registration, the composition of the file and set by order of the Minister of Health. Poisonous substances can enter the composition of cosmetic products and personal hygiene only if they appear on a list established by decree which fixed for each poisonous substance and for each product type, doses and concentrations at not exceed. The Medicines Agency of Madagascar may prohibit reasoned decision setting or maintaining the market for consideration or not cosmetics or personal care products pose a danger to the user. Article 149.- Insecticides and miticides to be to be applied to humans and products for maintenance or application of contact lenses must, before being placed on the market for consideration or gratuitously , subject to a visa issued by the Medicines Agency of Madagascar. Section 2 Dietary products Article 150.- A dietary product is a product for a specific food which, because of its special composition and its manufacturing process is different commodities

46 food for normal consumption and is suitable for the sought nutritional purpose; it is marketed to indicate that it meets this goal. The sale of dietary products is not reserved exclusively for pharmaceutical establishments. The manufacture, import, export or distribution of dietary products are subject to authorization. However, for public health reasons, the Minister of Health may prescribe by order special conditions for this type of product, including those relating to the composition, packaging, sales names, labeling, presentation , advertising and terms of production control. The provisions of paragraph 2 of Article 146 shall also apply to dietary products. Section 3 Medical devices

Article 151.- The term medical device means any instrument, apparatus, appliance, material, product or human origin nor animal, or other article intended by the manufacturer to be used in humans for medical purposes and whose principal intended action is not obtained by pharmacological or metabolic means but whose function can be assisted by such means. Article 152.- The medical devices are sold exclusively in pharmacies except intrauterine device placed at the disposal of the public at the medical units and establishments as contraceptives. However, the Minister of Health may authorize the sale of medical devices in specialized shops. Manufacturing methods, information and sale of medical devices will be subject to a decree of the Minister of Health. The introduction of new contraceptive medical devices will be subject to a decree of the Minister of Health on the advice of a committee formed by health professionals in the public and private sector. TITLE II EXERCISE OF PHARMACY CHAPTER GENERAL CONDITIONS Article 153.- are reserved exclusively to pharmacists, preparation, manufacturing, division, packaging, import, export, wholesale medicines and other pharmaceutical products subject to the same provisions. Except as provided in Articles 202 and following of this Code, are reserved exclusively to pharmacists, retail and delivery against payment or for free medicines and other products subject to the same provisions as well as breastmilk substitutes. Article 154.- are reserved to pharmacists and veterinary preparation, wholesale and retail of veterinary medicines.

47 Is reserved to pharmacists and opticians selling sterile solutions for eye contact lenses. CHAPTER II OF THE PROFESSION OF PHARMACIST Article 155.- No pet exercise the profession of pharmacy if it meets the following conditions: - holds a degree in pharmacy; - Malagasy nationality or be a national of a country with which a reciprocity agreement has been signed and that, within a quota set each year by order of the Minister of Health; - Fluent in Malagasy; - Be resident in Madagascar; - Not to have pharmaceutical activity outside the Malagasy territory; - Be on the roll of the National Pharmacists of Madagascar; - Guaranteeing all aspects of professional conduct; - To register his degree at the court of the place where he exercises his activity, and this in a period of one month from the date of taking activity. Article 156.- No one can practice pharmacy outside a pharmaceutical company received official permission to open. No person may practice privately the profession of pharmacist, lab medical biology analysis, import business, export, wholesale or production, if n 'authorized by the competent administrative authority. This permission does not relieve the pharmacist of the other formalities relating to the exercise of a commercial or professional activity. For the particular case of pharmacists officials, they can, if they meet the requirements to the abovementioned Article 155, open a pharmacy in its name, the authorization of the supervising Ministry after consultation with the National Council of order of Pharmacists, provided that they designate a responsible pharmacist to direct said dispensary.

They are therefore subject to the obligations of responsible pharmacists whose terms are set by regulation. Officials pharmacists, on exemption granted by order made by the Minister of Health, exercise as Head Pharmacist, part-time following a list of well-defined loads, a pharmaceutical company in public or in a inter-company organization nonprofit. Nevertheless, the authorization granted herein shall be strictly personal and validity automatically ceases when replacing the Pharmacist initially concerned on behalf of the Responsible Pharmacist successor. Article 157.- The responsible pharmacist working in a factory or the like of medicines and preparation must meet the conditions listed in Article 155 concerning the exercise of the profession of pharmacy. The pharmacist in charge of a pharmaceutical industry must be in possession of an industrial pharmacist degree or a pharmacy degree and a minimum of three years recent experience in a manufacturing pharmaceutical products. 48

The responsible pharmacist supervises the activities of all other qualified persons of the facility and determine their functions and responsibilities. The responsible pharmacist applies the principles and guidelines related good manufacturing practices, distribution, promotion and publicity recognized by the Malagasy State. Article 158.- Any pharmacist on the roll of the Order is subject to the requirements of the ethics of pharmacists, including the provisions of the current legislation on Ethics of Pharmacists. A pharmacist shall personally exercise his profession. Using a pseudonym for the exercise of the pharmacy profession is prohibited. Graduation can not be registered as an institution. A pharmaceutical establishment can remain open in the absence of Pharmacist if it is regularly replaced. Alternative arrangements and procedures that require the opinion of the Council of the Order are fixed by Order of the Minister of Health. Article 159.- Any pharmacist who wishes to cease activities must inform the Minister for Health and the National Council of the Order of Pharmacists. Any pharmacist who interrupted their activity and wishes to resume subject to the requirements with Article 155 of this Code. Article 160.- The assistant pharmacist performs duties under the responsibility of the holder or pharmacist responsible for pharmaceutical establishment pharmacist. The assistant pharmacist, to practice the profession of pharmacy is subject to the requirements with Article 155 of this Code. Article 161.- A pharmacist is authorized to seek help his pharmacy by one or more qualified people whose training is entirely up to the owner pharmacist responsibility. They fulfill their tasks under responsibility and effective control of a pharmacist, their criminal responsibility remains engaged. Article 162.- No pharmacist may be assisted by a doctor in his dispensary in any capacity whatsoever. Article 163.- Is prohibited any agreement according to which a pharmacist ensures a medical practitioner, a dentist or a midwife, a profit of any kind on the sale of pharmaceuticals, medicinal or hygienic as they may prescribe. Prohibited the creation of companies or associations whose purpose or activity is to

Seek, encourage, facilitate, or distribute cash for themselves or for third parties, interest or dividends in relation to the prescribing or dispensing medicines and pharmacy items.

49 are prohibited pharmacists or his employees from soliciting orders from the public. All orders delivered outside the pharmacy can be delivered in sealed package bearing the name and address of the customer. It is, furthermore, prohibits pharmacists to place orders outside of licensed wholesalers.

CHAPTER III EXERCISE OF ILLEGAL FUNCTION PHARMACIST Article 164.- Exercise illegally pharmacist features: - anyone who sells and provides the public with a drug, or preparing a drug without holding the diploma pharmacist recognized by the Malagasy State and the College of Pharmacists, save as otherwise expressly specified by this Code; - Any non-pharmacist or any company not owned by pharmacists and addicted to import or wholesale distribution of drugs, save as otherwise provided the provisions of this Code; - Any person or corporation operating a pharmacy without holding a decree issued by the Ministry of Health in accordance with the provisions of this Code; - Any person or company who not provided with an authorization issued by the Minister of Health, manufactures drugs. TITLE III

PHARMACEUTICAL ESTABLISHMENTS CHAPTER I COMMON PROVISIONS Article 165.- The opening and operation of any establishment manufacturing, import for wholesale, wholesale, dispensing medicines and similar products, are subject to authorization by the Minister Health after consulting the Order of Pharmacists. The authorization is issued on behalf of the owner of the pharmaceutical company in the case of a natural person or on behalf of the owner company. It is not assignable. The accumulation of pharmaceutical activities: manufacture, import, wholesale, export, dispensation of medications and related products is prohibited unless exemptions granted by order of the Minister of Health, after consulting the Council of the National Order of Pharmacists. In case of dispute, the provisions of the Code of Health and Code of Conduct take precedence over those of the Commercial Code. Article 166. An order of the Minister of Health determines the requirements, the composition of the file and the specific criteria for each type of pharmaceutical preparation and their location on National Territory. The application shall be addressed to the Minister of Health by the responsible pharmacist already designated. It gives rise to the perception of a fixed fee, the amount is 50

Determined by joint order of the Minister of Health and Minister for Finance and Budget. Article 167.- The authorization is granted by the Minister of Health after consulting the Board of the National Order of Pharmacists. It is granted or denied within three (3) months from the filing of the application for authorization. Refusal of authorization must be given. Authorization to open and exploit a pharmaceutical establishment is granted for an indefinite period. Article 168.- The opening and operation of all pharmaceutical establishment manufacturing, wholesale distribution and import are subject to the effective exercise of Responsible Pharmacist. Article 169.- Any pharmaceutical manufacturing facility, distribution, dispensing and sale is subject to inspection by pharmacists inspectors under the Medicines Agency of Madagascar. However, inspectors doctors, district health managers can inspect the deposits of medicines within their constituency. Article 170.- In the interest of public health, the Minister of Health may, report and advice of a pharmacist-inspector and after consulting the Board of the National Pharmacists Association, at any time order the closure temporary for a period of three months of a pharmaceutical company if the conditions attached to the granting are no longer met. After a written demand remained ineffective on expiry of the time allowed, the Minister of Health may, on a proposal from the Medicines Agency of Madagascar or the Directorate of Management Inputs of Health, Laboratory Traditional Medicine (DGILMT) revoke the authorization. The decision to temporary or permanent withdrawal of the authorization to open and exploit a pharmaceutical establishment must be substantiated. Article 171.- Any substantial modification of the initial conditions of the facilities, equipment or organization of the institution must, moreover, be authorized by the Minister of Health, according to the same procedure as laid down in Article 163 of this Code. Article 172.- Termination of activities of a pharmaceutical establishment which has been authorized to be notified to the Minister of Health at least three (3) months before the date set for such termination and shall be brought to public knowledge by way of insertion in the Official Gazette of the Republic. Article 173.- Any establishment manufacturing, wholesale and dispensing of medication is required to have a copy of the pharmaceutical legislation and a copy of the Code of ethics of pharmacists.

51 CHAPTER II OF PHARMACIES OFFICINE

Article 174.- The term community pharmacy, the institution dedicated exclusively to the provision to the public of medicines and other health goods, as well as the execution of Magistral and preparations under the supervision of a pharmacist. Article 175.- Operating a community pharmacy is incompatible with the exercise of another profession, notably that of doctor, dentist, veterinary surgeon, midwife, nurse (e). Pharmacists provide in their dispensary simple drugs, pharmaceutical products and preparations described in the Pharmacopoeia. Pharmacists can not do in their dispensary that trade in pharmaceuticals and pharmaceutical products defined by this Code. Article 176.- The pharmacist must own the dispensary he holds. Pharmacists are allowed to form between them a company to operate a pharmacy. Each member of the Society pharmacist is required for the personal exercise and is fully responsible for the rules of conduct applicable to the profession. To encourage the liberalization of operations for the sale of drugs and other health goods, the following principles govern the different forms that can take the establishments engaged in pharmaceutical business: Pharmacists may join under the provisions regulating commercial companies, while respecting the specificities of the profession of pharmacy. These principles should be applied to text object taken by the Minister of Health. Managers and partners are liable towards third parties. No limit is given to tortious liability and quasi-criminal managers, who must be guaranteed against occupational hazards. A pharmacist whose diploma is already registered to operate a pharmaceutical institution or pharmacy or for any reason whatsoever may associate with one or more pharmacists or whose qualifications are not yet Having recorded a creation of a dispensary. The newly established pharmacy must be managed by the associated pharmacist whose diploma is not yet registered. A pharmacist can not be associated with more than two pharmacies. The capital should belong in its entirety to one or more pharmacists who filled conditions of practice of pharmacy in the country. Article 177.- Pharmacists are also allowed to form individually or between a limited liability company to operate two pharmacies at most, provided to comply with paragraphs 6, 7 and 8 of Article 176 regardless of the number of associated pharmacists and pharmacy's stewardship is ensured by one or more of the associated pharmacists. 52

Article 178.- Any associate pharmacist whose diplomas are registered to operate a pharmacy can not have any pharmaceutical activity unless exemptions granted by the Minister of Health. is null and void, any provision intended to establish the ownership or joint ownership of a pharmacy owned by a non-graduate. Pharmacies are subject to the conditions laid down in Chapter I, Title III of Book III of this Code. Article 179.- The operating authorization is conditional, subject to the conditions laid down for the exercise of pharmacy, the criteria set by the Minister of Health under the National Pharmaceutical Policy. Article 180.- Any opening a new pharmacy, transfer a pharmacy from one place to another, and any assignment or change of ownership is subject to the granting of a new permit issued by order of the Minister health, after consultation with the National Council of the Order of Pharmacists. Article 181.- The owner of a pharmacy Pharmacist must personally exercise his profession. In all cases, the drugs must be prepared and dispensed by a pharmacist or under the direct supervision of a pharmacist. However, the holder may engage an assistant pharmacist. The latter must be registered with the Medicines Agency of Madagascar, having been approved by the Council of the Order and is appointed by decree of the Minister of Health. Pharmacists are required to update their knowledge through postgraduate training. Pursuant to Article 75 of this Code, the pharmacy pharmacist has a duty to fulfill the obligations imposed by the daycare and emergency. Any pharmacist who refuses to submit to it is liable to the penalties provided for in Article 331 of this Code. Article 182. As required, a decree of the Minister of Health determines the number of dispensaries allowed to settle in a given locality in proportion to the number of inhabitants and a minimum distance required between pharmacies. CHAPTER III INTERNAL USE OF PHARMACIES Article 183.- internal use is defined as pharmacies, hospital pharmacies and other health care institutions, public or private, whose activity is limited to the delivery of drugs and medical consumables: - inpatient in hospitals; - To patients in consultation in clinics and other health facilities . They are subject to conditions established by the Chapter, Title III of Book III of this Code.

AND DISTRIBUTION Article 184.- pharmaceutical establishment is defined as any big accredited institution, public or private indulging outside or local purchase for sale in the state to people or structures authorized to provide drugs, pharmaceuticals and medical devices. The pharmaceutical wholesale business has to import products not available from local manufacturers. The pharmaceutical wholesale establishments are subject to the obligation to guarantee permanently an assortment of essential drugs to meet the demands of dispensation establishments to have permanently a minimum stock and to ensure the distribution of products in the shortest deadlines. A pharmaceutical wholesale business must be able to ensure directly import and / or have a minimum range of 2,000 references covering all therapeutic classes. The criteria payable for an open request are specified by order of the Minister of Health. The premises for the activities of an establishment of wholesale pharmaceutical products must be easy to access and reserved exclusively for this purpose. The building must have the sign indicating the name of the institution and full address. The building for the activities mentioned in above must have a total area of ​​three hundred square meters minimum. It must include obligatorily: - a part for the administration of the institution; - A drug reception room; - One delivery room; - Storage warehouses adequately ventilated and equipped with wall thermometer; - A lavatory; - Handling equipment, storage and storage pallets, shelves , refrigerators ...; - The premises housing the hall of distribution and storage stores must be developed, adapted and maintained to suit the operations conducted there. Any form of advertising or unfair competition shall be prohibited in any establishment of wholesale pharmaceuticals. Specifically, an establishment of wholesale pharmaceuticals can not practice any form of comparable sales to the practice of street vendors. The pharmaceutical wholesale establishments are not allowed to sell directly or to the public, nor the doctors, nor to other health professionals, other than the institutions of approved distributions, pharmaceutical products they sell in large. However, they are 54

allowed to bid in tenders emanating from institutions of a public character of the Malagasy State, as well as non-profit Private Health Facilities statutorily under a District Service of Health, pursuant to the provisions of Article 189 below. All wholesale pharmaceutical establishment is subject to the conditions set by the first Chapter, Title III of Book III of this Code. The business of importing and wholesale distribution is restricted to wholesalers

Dispatchers importers. Article 185.- Any wholesale pharmaceutical establishment should be placed under the responsibility of a Head Pharmacist. Article 186.- Any Pharmacist is personally liable under the laws and regulations in exercise of the pharmacy profession, without prejudice, where appropriate, of joint liability of the company. It is subject to all the obligations imposed on the pharmacist, especially regarding inspections conducted by inspectors in pharmacy. Article 187.- Any establishment or wholesale, or simple drugs or chemicals for pharmaceutical and packaged for sale to medical weight, or pharmaceutical compositions or preparations should be the property of a qualified pharmacist State or that of the managing company or to the Directorate General of a pharmacist is involved Head and in this case, the company's capital must belong mostly to one or more pharmacists in the proportion of 51 % for pharmacists and 49% for anyone not a member of the profession. It may be in whole or part, conceded in lease management to a company in the same conditions as above. The methods of exercising stewardship rent are determined by regulation. Managers and associates are accountable to others. No limit is given to the criminal or quasi-criminal liability of Managers. Article 188.- If a collective decision taken at the level of senior management or stewardship violates the ethical rules of the profession of pharmacist and / or the National Pharmaceutical Policy, the Responsible Pharmacist retains full prerogative it holds its quality and ethical rules to which he must submit, to oppose the decision, suspend implementation and enter the Ministry of Health about the fate of the decision referred. Article 189.- Importers wholesale establishments may sell directly to the public Formations Sanitary or private nonprofit within statutorily District Health Service of the location, generic subject they get Ministerial approval for Health and are managed by a responsible Pharmacist or that many pharmacists are co-owners. Article 190.- The principles listed in sections 185-189 are set by decrees issued by the Council of Government on the proposal of the Minister of Health. Article 191.- The import of similar drugs or products do not meet the specifications degraded, fraudulent, expired, falsely labeled, without Authorisation on the market or whose Authorisation Market has been removed or has not renewed or in other countries in Madagascar is prohibited.

55 Article 192. A decree of the Minister of Health will determine the number of import facilities, wholesale and distribution in proportion to the total annual imports of medicines made in the Private Sector. The issuance of such institutions operating permit can be performed only in accordance with the said Order. CHAPTER V MANUFACTURING FACILITIES AND OPERATIONSPHARMACEUTICALS Article 193.- The term factory or pharmaceutical production any institution engaged for sale or export, the total or partial preparation of medicines and related products. Is considered total preparation, making the product from the purchase of raw materials to finished product. Are considered partial preparations, with control related obligations, division, packing loading and presentation of these drugs, goods and objects. Any facility manufacturing or pharmaceutical production may be the property: 1 - either a natural person having the status of pharmacist; 2 - is a society consisting of individuals not pharmacists and pharmacists, governed by the provisions regulating civil societies; 3 - is a public limited company, provided: - that the shares are registered shares; - That half the members of the board or pharmacists. Any facility manufacturing or pharmaceutical production is under the responsibility of an pharmacist. The responsible pharmacist should be part of the Board of Directors of the Company concerned. Article 194.- The responsible pharmacist practicing in a manufacturing or pharmaceutical production must meet the conditions listed in 155 and 156 of this Code concerning the exercise of the profession of pharmacy. The pharmacist must be assisted by assistant pharmacists whose number is proportional to the size of the facility staff. manufacturing establishments or production must manufacture and sell their products exclusively to benefit distribution and wholesale establishments. However, they can export their products. Establishments manufacturing or production are subject to the general provisions in Articles 165 and following governing pharmaceutical establishments.

56 Article 195.- Any request to open a manufacturing or production or branch must have a record showing that the manufacturer will comply with the good manufacturing practices recognized by the Malagasy State . The authorization to operate a manufacturing facility is issued by the Minister for Health after joint opinions of the Ministry of Trade, Minister for the Environment and the Ministry of Water. The opening authorization indicates the pharmaceutical forms for which it is valid and the place of manufacture. Article 196.- The holder of the authorization to open a manufacturing facility or pharmaceutical production must take all appropriate measures to ensure the responsible pharmacist can fully assume its mission and assisted as required under its responsibility by other qualified persons, as provided in the regulations. By qualified person means a pharmacist, chemist or any other person whose scientific qualifications and experience are recognized by the Malagasy State. The pharmacist must inform the Minister of Health of any disagreement who oppose any of the various organs of the establishment on the application of rules laid down in the interest of health public. TITLE IV CONTROL BODIES CHAPTER AGENCY OF DRUG MADAGASCAR Section 1 General Provisions

Article 197.- In application of Articles 4 and 5 of this Code in connection with the establishment of the National Pharmaceutical Policy, the Minister of Health gives a public institution of Administrative character with legal personality and financial autonomy under the name "medicines Agency of Madagascar," a mission of implementing and monitoring the quality of medicines in Madagascar, in order to guarantee independence, the scientific competence and administrative efficiency studies and controls on the manufacture, testing, therapeutic properties and the use of drugs, in order to ensure the lowest cost, the health and safety of the population and contribute to the development of industrial and pharmaceutical research . Article 198.- The Agency Drug Madagascar is responsible for: 1 - the registration of human medicines and other pharmaceutical products for their grant Authorisation Market in Madagascar; 2 - Inspection of pharmaceutical establishments throughout the national territory; 3 - to participate in the implementation of related laws and regulations: - clinical trials, manufacturing, importation, placing on the market of medicines and other pharmaceutical products;

57 - for narcotics, psychotropic and other poisonous substances used in medicine, as well as laboratory reagents; 4 ° - to collect and assess information on unexpected or toxic effects of drugs and the misuse of psychoactive substances and to take the matter any measure to safeguard public health; 5 ° - to propose any measure contributing to the development of research and industrial activities in the field of medicine, and thus promote the complementary relationship between the public and private sectors; 6 ° - to coordinate and carry out quality control of drugs through the national laboratory quality control; 7 ° - to participate at the request of the Minister of Health in the development or amendment of laws and regulations governing its activities; 8 ° - to propose to the Minister of Health all matters related to the areas under its jurisdiction. The administrative and financial organization of the agency's Drug Madagascar is fixed by decree of the Council of Government on proposal of the Minister of Health. Section 2 From the inspection Article 199.- The functions of control and inspection of pharmaceutical establishments nationally, assigned by this Code to Madagascar Drug Agency are carried out by pharmacists inspectors who must pharmacist state diploma and who have received training on inspection techniques. Pharmacists inspectors are responsible for:

1 - control in pharmaceutical facilities and some hands that they are running all the requirements of laws and regulations that relate to the practice of pharmacy. As such, they are vested with the judicial police service, in accordance with Article 128 of the Criminal Procedure Code and are empowered to identify offenses throughout the national territory, to gather evidence, to identify the perpetrators and to proceed seizures. They are bound by professional secrecy. They must be sworn before being allowed to perform their duties; 2 - to respond to any request for technical expertise or investigation made by the Minister of Health or by the President of the National Council of the Order of Pharmacists or request a court proceeding. The Medicines Agency of Madagascar may use interventions agents authorized by a special law to find and prosecute offenses related to the implementation of legislation and regulations on drug marketing. These agents fall under the Ministry of Trade and contribute to the police in accordance with Article 128 of the Criminal Procedure Code. Article 200.- The expenses of any kind resulting from the operation of the inspection of pharmaceutical establishments are the responsibility of the Medicines Agency of Madagascar. The quality of pharmacists inspectors, their mission, function and organization of their service are defined by decree of the Minister of Health.

58 CHAPTER II NATIONAL LABORATORY QUALITY CONTROL OF DRUGS Article 201.- The National Laboratory of Drug Quality Control, attached to the Agency Drug Madagascar is responsible for monitoring the quality of human drugs and all licensed drugs and provided the market or dispensed to Madagascar and compliance thereof with the specifications presented at the request of the marketing or import authorization . The Medicines Agency of Madagascar may be used, where appropriate, the provision of other approved laboratories with which it concludes agreements. The operating procedures of the National Laboratory of Drug Quality Control are determined by decree of the Minister of Health. TITLE V PROVISIONS RELATING TO DEPOSITS OF DRUGS, TO A CHEMIST PARTICULIRE MANAGEMENT AND MEDICINAL PLANTS CHAPTER DRUGS DEPOSITS

General rules Article 202.- The deposition of drugs is a central sales and distribution to the public of essential pharmaceuticals, basic necessities, including the operating permit is issued as a palliative by the Minister of Health, non-pharmacists in locations where there is no pharmacist having a dispensary open to the public. Medicinal products authorized to be provided by these deposits are included in a list established by the Ministry of Health and custodians must meet the requirements laid down by order of the Ministry of Health. In particular should be of Malagasy nationality, without prejudice to the provisions contained in international or taken in execution of these agreements agreements. The drug depot is subject to the rules of dispensation. Regular opening a pharmacy prohibits any subsequent authorization deposit opening sis drugs within ten kilometers (10 km) and invalidates any prior authorization issued in favor of an already functional drug depot after within three months of the effective aperture of the pharmaceutical dispensary. In accordance with the above provisions and retroactive effect of the law and from the date of signature of this Act, any deposit or unopened drugs legally within less than ten kilometers (10 km) of an existing dispensary must cease all activities and close the deposit concerned. In this case, an order of the Minister of Health sets the repeal of authorization to open the filing of drugs involved on referral to the pharmacist knowingly. This Order shall apply, upon publication, and is subject to appeal before the Courts and the State Council of the Supreme Court.

59 Without prejudice to the sanctions provided by the Penal Code relating to unlawful exercise of a profession, every transgression exposes the violator to the penalties provided under Article 332 of this Code. Article 203.- In case of violation of rules of drug depository exercise requiring the closure of the disputed deposit, the District Medical Inspector, after having ascertained, draws up a report which the original is sent to the administrative authorities responsible for ordering the closure of deposits deciduous authorization drugs. A copy of the minutes must be notified by administrative channels to relevant custodians acknowledge receipt. The administrative authority merely ordered the closure of the establishment, the physical execution of the deed done by another authority or the Bailiff or the Agent Verbalisateur. However, the closure of a drug depot can not in any way give opening action in damages against the State. Article 204.- It is forbidden to use drugs custodian of retailers exclusively for dispensing pharmacies, in particular the word "pharmacy", the emblematic green cross pharmacy and the caduceus. CHAPTER II MANAGEMENT OF PHARMACIES A PARTICULAR

Article 205.- The term Pharmacy Wholesale District (PHAGDIS), the warehouse of pharmaceutical products located at Place chief of each health district. It is intended to provide drugs, medical supplies, contraceptives and laboratory reagents hospital complexes District Reference and Health Centers Base public and private nonprofit within the district. Article 206.- The term Community Pharmacy Management (PHAGECOM), local storage and dispensing prescription pharmaceuticals to patients. It is located in the home Toilet Training is managed in co-management of designated representatives of communities and officials of the Health Center. The regulations define the rules for the PHAGDIS and PHAGECOM. CHAPTER III OF MEDICINAL PLANTS AND OTHER NATURAL ORIGIN Article 207. The term herbal medicine, disease treatment by medicinal plants. Article 208.- The term medicinal plant, any plant whose all or part delivered in the state, has a curative or preventive under scientifically proven or traditionally recognized. Article 209.- The term herbal plants and mixtures of dried plants, prepared in advance for use as an infusion or decoction. Herbal teas are subject to the provisions on herbal medicines.

60 The term natural product, natural product other than medicinal plants, such as minerals or animal products, used either as is or as preparation for therapeutic use. Article 210. The Commission of the Malagasy traditional medicine, under the authority of the Minister of Health, is responsible for gathering information on plants and other natural products that can be used therapeutically and codify their jobs and the preparation of pharmaceutical drugs that are made. A decree shall determine its composition, the appointment of its members and its mode of operation. Sale of medicinal plants, manufacturing and sale of herbal medicines are set by decree of the Council of the Government on the proposal of the Minister of Health. IV BOOK OF CONTAGIOUS DISEASE AND OTHER

FLEAUX SOCIAL PART I OF TUBERCULOSIS Article 211.- Within the National Programme against Tuberculosis and one of Expanded Program on Immunization, vaccination with BCG TB vaccine is mandatory at birth. Article 212.- A decree on the report of the Minister of Health, after consulting conformity of the National Commission for Hygiene and Health determines detailed rules for vaccination technique the tuberculosis vaccine BCG , any cons-indications, the practice of re-vaccination, control of tuberculin reactions before or after vaccination. Article 213.- The TB mutual aid committees and provide health education under the control phthisiologists doctors for Regions and Municipalities: a. aid to TB or their families; b. the organization of health propaganda tuberculosis.

Strengthening and effective implementation of the functioning of these committees will be subject to a decree of the Minister of Health. Article 214.- In the continuation of the National Programme against the tuberculosis, the latter continues to be in the list of notifiable diseases throughout the territory of the Republic of Madagascar. Article 215.- The sale of TB drugs may be declared closed to the pharmacy and medicine depots, on proposal of the Minister of Health to prevent the emergence of resistant strains of TB by misuse and uncontrolled of these products. To avoid out of stock of anti-TB drugs, supplying the central level should be regular.

61 Any patient admitted TB must be treated according to the schemes and rules recommended by the National Program against Tuberculosis. In case of change of residence, the patient should tell their Physician who followed the patient's record to the new doctor through the Medical Inspector of the District. Any patient admitted with tuberculosis who refuses to submit to the hygiene or bacteriological examinations, monitoring required by his condition, or who has not completed the prescribed treatment should be a measure determined by the doctor treating and / or by the local administrative authority. TITLE II LEPROSY CONTROL Article 216.- Any patient admitted lepers must be officially registered at the competent Public Health Training residence, on a register established for that purpose. Article 217.- Any patient undergoing treatment must in case of transfer of residence, prevent his doctor that sustains the patient's file to the new doctor through the Medical Inspector of the District or the Service leprosy of the Ministry of Health in Antananarivo. Any patient admitted lepers must follow a treatment according to the scheme and the rules recommended by the National Leprosy Programme. In case of refusal, health and local government can be entered for compulsory treatment. The hospitalization is not required, except for complicated cases mentioned in the technical guidelines of the Ministry of Health. treatment in patients retain their rights at work and their professional privileges. Article 218.- The Associations or Committees for the Fight against Leprosy and health education, the establishment may be caused by the Minister of Health, provide assistance to lepers and their families, as well as the organization of sanitary propaganda favorable to leprosy. The organization and functioning of these associations or committees are established by decree of the Minister of Health. Article 219.- After advice of the National Commission of Hygiene and Health, and the proposal of the Minister of Health, leprosy can be classified by order notifiable disease in all or part of the territory of the Republic of Madagascar . TITLE III MALARIA Article 220.- The management of cases of malaria at home is supported by a system of providers with the Global Supply Non Stop Drug or FANOME and a community-based distribution system. 62

Means a system providers with the Global Supply Non Stop Drug, one that provides for participation of the patient to the drug costs in health facilities where the patient is treated. Community-based care also provides for participation of people in drug costs, but the last are sold directly to the lowest level of the same locations in the absence of Health Facilities. An order in Council of Government sets the organizational arrangements for the management of malaria cases community-based as well as the creation of a Technical Advisory Committee for Monitoring and Orientation of the distribution circuit. Article 221.- The promotion of a wider use of insecticide-treated nets is one of the state's obligations. The supply of nets and insecticides can be left partially in the private sector responsibility. But the quality control of insecticides is for the state. Re-treatment of nets can be conducted by community associations and NGOs. But the technical inspection, supervision of re-treatment operations are part of the State's obligations. The service of the fight against malaria determines the vector control strategy in a given area écoépidémiologique. The decision to implement the operations of intra- domiciliary residual insecticide back to the state. The conduct of insecticide spraying operations up to the health authorities of the Districts in the alert system of the fight against epidemics. Specific measures to protect the environment and human health from the health and environmental risks of chemicals used shall be prescribed by regulations of the Ministries of Health and Environment. TITLE IV THE FIGHT AGAINST THE PLAGUE Article 222.- The detection of cases of human plague is carried on a suspicious person alive and in control of death and possibly by post-mortem samples. Article 223.- The fever is a notifiable disease. All plague cases or suspected cases should be reported immediately by all staff is aware of the authority or, failing that, to the nearest administrative authority. Article 224.- The verification of death and post-mortem samples intervene whenever the check reveals a pooled mortality, abnormal and whenever a suspicion exists, clinical or epidemiological plague. Medical examiners or auditors deaths doctors and their deputies have the right to enter homes where the dead are and, in case of suspicious death, to do all the necessary samples. They operate in the presence of one or two members of fokonolona. 63

The post-mortem samples can be made systematic in the threatened districts for a specified time, by order of the Minister of Health on a proposal from the competent authority at the Regional level. Postmortem samples will be necessarily carried out on the bodies of deceased persons on the territory of so determined Districts. Article 225.- The audit of deaths and withdrawals from the deceased may be required by the health authority, ordered or even on oral request, and thus be made by free doctors in places where there is no physician or paramedical authorized for this purpose, and without compensation. When it is a case of suspicious death or a death occurring in a mandatory audit area, burial can be made after verification of death and the necessary samples without waiting for the results of laboratory tests . Patients with fever or suspected to be suffering from plague plague are isolated as directed by the health authorities. Isolation may occur in hospital or at home Any person with fever or suspected of being plague reached must comply with medical prescriptions until disappearance of the danger of contagion. Article 226.- The people who had direct or indirect contact, making possible conditions in the transmission of plague, with plague or with fever suspected patients are subject to chemo-prophylaxis sulfamidée accordance with technical guidelines. The duration of the isolation is ten (10) full days. People who have been in contact with plague patients or suspected patients of plague, the health personnel of different prophylaxis teams are required to submit to medical prescriptions, particularly regarding disinfection measures, pest and chemoprophylaxis. Article 228.- The reopening of a grave or pit in which was buried a plague can occur after a deadline set by the relevant health authority. The exhumation is subject to the approval of the administrative authority and is performed under control of the Inspector Surgeon General or a competent health worker can represent. Article 229.- The traffic and transportation of all goods or any goods which could either be contaminated or being vectors of fleas or rats, are prohibited within the contaminated districts of plague, except authorization from the health authority. The output of all commodities or goods which could either be contaminated or being vectors of fleas or rats outside of contaminated constituency plague is prohibited unless authorized by the health authority. Any outgoing transportation of a contaminated area must be recognized subject to a pest by contact insecticides, according to the requirements of the health authority. A certificate of disinfestation will be issued to the skipper.

64 Article 230.- The measures to be adopted against the germ of the plague, against the vector and virus against the marine tank, are ordered by the local health authority and executed under its control. Article 231.- The fight against the plague requires the treatment of patients, medical supervision and chemoprophylaxis subjects contacted and disinfestation of contaminated area and epidemiological surveillance. No one can oppose the implementation of these measures. TITLE V OF THE FIGHT AGAINST OTHER CONTAGIOUS DISEASES

CASES AND OTHER EMERGING AND RE DISEASES Article 232.- The organization of the fight against other infectious diseases in general, and the fight against cancer, mental illness, debilitating diseases and other scourges case social is governed by the laws and regulations, under the guidance of the Minister of Health and other relevant health and administrative authorities. TITLE VI OF INFECTIOUS DISEASE WHICH DIARRHOEAL CHOLERA Article 233.- transmitted diarrheal diseases in general and cholera cases in particular should be a mandatory declaration by public and private health professionals to the competent health authority. While cholera cases must, in the shortest possible time, subject to notification to the World Health Organization by the aforementioned competent health authority. The first suspected cholera occurring in an area previously considered free must be confirmed in the laboratory and the results forwarded to the World Health Organization as soon as possible, by the same competent health authority. Article 234.- ago when suspected cholera: - in a region apparently spared cholera, an acute episode of watery diarrhea usually with vomiting causes severe dehydration or death in a patient over the age of five (5 years ; - In a region where an outbreak of cholera breaks out, a patient aged two (2) years suffering from acute watery diarrhea with or without vomiting. Must evoke a cholera outbreak in the following cases: - a patient of more than five (5) years has severe dehydration or dies from acute watery diarrhea episode; - A sudden increase in the daily number of acute watery diarrhea are observed, especially if s'git of watery stools "rice water" containing lumps typical of cholera. Article 235.- In order to eliminate any danger of spread of cholera, it can be taken by the Minister of Health a decree establishing the state of alert in a locality or a localized geographical area and where should be applied for an indefinite period, hygiene and disease prevention measures.

65 For this purpose, any person entering or leaving an infected area should be the subject of prophylactic measures. Article 236.- For better prevention against cholera epidemics, the authorities concerned in collaboration with the Ministry of Health to provide people access to clean water and properly treated, a good workforce Clean environment and food safety. To promote the use of latrines, the concept of hygiene and sanitation must part of school curricula to teach students and awareness campaigns conducted especially in women. Article 237.- A National Interministerial Coordination Committee gathering senior officials of all ministries and services is created in order to ensure the cooperation of the relevant sectors, to ensure speedy implementation of the above preventive measures and make effective the fight against the spread of the epidemic. A decree of the Council of Government, on proposal of the Minister of Health, determines the organization and functioning of the Committee. Article 238.- In order to fight and prevention against the spread of cholera and up

The implementation of effective training to the clinical management of acute diarrhea, all health professionals should use the document published by the World Health Organization and entitled "Guide to the fight against cholera "or any other document received a validation from the Ministry of Health. Article 239.- The patients with suspected cholera diarrhea must comply with support for measures in designated health centers and chemoprophylaxis enacted for this purpose. Populations from infected areas and moving to another region or locality must comply with chemoprophylaxis measures required. Article 240.- Non-compliance of the provisions referred to above article exposes the offender the immediate removal to the place of origin or its compulsory and immediate quarantine.

TITLE VII OF INFECTIONS SEXUALLY TRANSMITTED Article 241.- Anyone with sexually transmitted infections must be examined and get treated until recovery. Article 242.- Without prejudice to the provisions of the Labour Law, the demand for control of the health of the worker by the employer for the purpose of detecting whether or not the worker is carrying sexually transmitted infection, what that 'either the reason, violates the right to privacy on the state of individual health and is prohibited. Control of the state of health of a worker requested by the employer is limited to the right to certification by licensed doctors for this purpose, to clarify how the health status of a worker is free, or assigned to infirmantes related diseases lifestyle impacting professional competence.

66 Article 243.- Without prejudice to the provisions of the International Health Regulations, actions on travelers arriving effected by control charges for Frontier Madagascar, whether an individual is or is not carrying sexually transmitted infection, are prohibited for affect the right of individuals to privacy of their health. Article 244.- Without prejudice to the provisions of the International Health Regulations, except in cases of repatriation or medical evacuation on Madagascar, the observation of a manifest disease state in a traveler entering Madagascar, authorize a medical examination control by the Border Health Services. Article 245.- In the event of indicating blood transfusion to a patient, regardless of his assignment, blood transfusion bear a specific examination to confirm its safe nature, is mandatory. Article 246.- The declaration of sexually transmitted diseases may be made compulsory by decree on proposal of the Minister of Health, on the advice of the National Commission of Hygiene and Health. Article 247.- Notwithstanding the provisions of Law No. 2005-040 of 20 February 2006 on the fight against HIV / AIDS and protecting the rights of people living with HIV / AIDS and those of its implementing regulations, any person engaged in prostitution must be identified and stuck. Special surveillance measures should be taken against them without waive the confidentiality obligations. TITLE VIII CONTROL OF THE ENVIRONMENT RELATED DISEASES

Article 248.- The diseases related to the environment are subject to further research and education. Specific measures of protection of human health through the development of the Operational Plan for Health and Environment must be disseminated and followed. Environmental indicators could generate effects on human health must be subject to monitoring and control. The provisions of organization of surveillance systems, information, warning, investigation and response are established by decree of the Council of Government on the proposal of the Minister of Health, on the recommendation of the Libreville Declaration . Any program, any plan, any project whose activities may affect human health is subject of the Health Impacts Studies, according to the text in force on MECIE (Mise En Accounting for Investments with the Environment). V BOOK OF FIGHTING DISEASE

NONCOMMUNICABLE TITLE OF FIGHTING MEASURES RELATED DISEASES

LIFESTYLES Article 248 bis.- The state must provide for needs of every citizen who, because of his age or his inability motor, sensory or mental, is unable to work, including through the establishment of social organizations characters.

67 Article 248 ter.- The Act provides for measures to eliminate inequalities affecting people with disabilities. The duration and working conditions should not prejudice the health or dignity of the worker. Article 249.- The list of diseases that apply these provisions as well as measures against chronic and debilitating diseases are determined by regulations made by the Minister of Health. This list may be amended under the same conditions as above depending on possible appearance of new forms of diseases. Article 250.- The implementation, in all areas, promotion of prevention of chronic noncommunicable diseases is set by regulations of the Ministry of Health. Article 251.- pursuant to Law No. 97-044 of 2 February 1998 on disability and subsequent legislation, the organizational arrangements and support for people with disabilities in the context of community-based rehabilitation are laid down by regulations. Article 252.- The associations against chronic diseases and disabilities provide support to patients and their families and participate in the organization of awareness campaigns on the subject. The organization and functioning of these associations are established by decree of the Minister of Health. Specifically, measures of injury prevention and violence must be established especially for road safety, the prevention of different types of violence, prevention of drowning, burns, falls, poisoning / intoxication. Any victim of trauma and / or violence is entitled to proper care from the place of the incident to the health facilities. TITLE II FIGHTING MEASURES EYE DISEASES

Article 253.- Any person with eye disease is entitled to proper care at specialized centers with equipment and consumables and medicines under the responsibility and under the direction of ophthalmology specialist. Under current regulations concerning both the services in the state that private centers or specialists, acquisition or collection of good eye health manifested by binocular vision incorporates and free from any pathology results the combined action of various strategies such as prevention, early diagnosis and the treatment of all diseases that may affect the integrity of vision. TITLE III CONTROL MEASURES AGAINST TOBACCO AND OTHER DRUG ADDICTION Article 254.- The list of products consumption can cause adverse health addictive character and which apply the provisions of this Title and that tobacco control measures and other addictions, is fixed by statutory instrument made by the Minister of Health, after consulting the National Office for combating anti-Tobacco (OFNALAT).

68 This list may be amended or increased, in the same conditions as above, according to new forms of known toxic spills on the consumer market. Article 255.- The main objectives of the National Office of Tobacco Control (OFNALAT) are: 1- Implement the provisions stipulated in the Framework Convention on Tobacco Control in order to protect the generations present and future of the devastating health, social, environmental and economic effects of tobacco consumption and tobacco smoke exposure and comprises: - measures for reducing demand for tobacco; - Measures for reducing the supply of tobacco; - Measures on environmental protection; - Scientific and technical cooperation and communication of information. 2 specify the orientation axes of the fight against drug abuse which should include measures of prevention, screening, diagnosis, treatment, rehabilitation and social reintegration; 3- "establish and complete as they emerge the list of products whose consumption can cause adverse health addictive character and which apply these provisions as well as the fight against drug abuse measures; In this list, including cannabis (rongony), khat, all drugs risky alcohol in all forms including alcohol illegally sold as fermented drink and manufactured (toaka gasy), tobacco smoking, chewing tobacco, snuff or suck; 4- strengthen existing struggles of measures and the implementation of new sanitary, social and security needed to reduce drug abuse and eradicate its worst effects; 5- recap and complete the list of laws and regulations constituting the legal framework for the fight against drug addiction. Propose improvements and the enactment of new legislation; 6- strengthen awareness campaigns against the causes of addiction.

Article 256.- The legal framework for tobacco control and other addictions to include in particular the following: • Law No. 61-053 of 13 December 1961 on the fight against alcoholism and its subsequent texts ; • Law No. 97-039 of 4 November 1997 on the control of narcotics, psychotropic substances and precursors in Madagascar and its subsequent texts;

• Law No. 2004-029 of 9 September 2004 authorizing the ratification of the Framework Convention of the World Health Organization on Tobacco Control; 69

• Decision of the High Constitutional Court No. 23-HCC / D1 of 8 September 2004 on the Law No. 2004-029 of 9 September 2004 authorizing the ratification of the Framework Convention of the Organization World Health Tobacco Control: • Ordinance No. 60-098 of 21 September 1960 on the regulation of beverage and its implementing regulations and its potential subsequent texts; • Laws and regulations in the fight against drugs and related criminal activities as well as those governing industrialization, import, marketing and consumption of tobacco products in Madagascar; • The regulations governing the establishment, organization and functioning of the National Office of Tobacco Control of the Ministry of Health. TITLE IV OF FIGHTING MEASURES MENTAL ILLNESS Article 257.- The list of diseases that apply these provisions as well as measures against mental diseases are determined by the regulatory text of the Minister of Health. Article 258.- This list may be amended under the same conditions as above depending on possible appearance of new forms of diseases. Article 259.- The main control objectives against mental illness are: 1- take into account progress in the prevention and diagnosis of mental illness, quality of care and type of drugs administered to patients with mental disorders, monitoring of patients left in family, social or in a non-hospital facility or hospital, rehabilitation and reintegration; 2 design on this basis a policy to promote mental health through the definition of the tasks of institutions providing hospital services dependent on the State or any legal person of public or private law involved in the implementation of the policy to promote mental health; 3- redefine the status of the mentally ill, its protection as a person incapable, major or minor child and adolescent; 4- set up a system of individualization of patient protection measures with mental disorders. As necessary, these objectives may be reassessed by statutory application made by the Minister of Health. TITLE V DUTIES AND MEASURES Article 260.- The Ministerial Departments, Institutions, NGOs and civil society have a duty to implement programs to promote the measures enacted in: • prevent all forms of non-communicable diseases, including workplaces, to practice sports and recreation in the

70 schools and universities and in all public places covered or deemed to be covered; • to include in the national plans, programs and development strategies, prevention, early diagnosis and appropriate management of the above mentioned diseases; • to work with financial partners to facilitate access to treatment of these diseases. Article 261.- In addition to any administrative measures or applicable font, breaching the provisions of the regulations intended to prevent the spread of non-communicable diseases is punished in accordance with Articles 329-330 of this Code, depending on the nature offenses committed in the field.

Article 262.- The oral conditions which are applicable herein provisions and measures against oral diseases are determined by regulation at the behest of the Minister of Health. BOOK VI OF THE HEALTH PROTECTION OF THE FAMILY PRELIMINARY OF GENERAL ON CHILD PROTECTIVE MOTHER AND Article 262 bis.- Health is the right of every person and the duty of the State and is secured by means of social policies and economic to reduce the risk of illness and other hazards and to facilitate universal and equitable access to all activities and services for the promotion, protection and recovery of health. Article 263.- The provisions regulating the health protection of the family, and more particularly of women and children, are inseparable from the provisions of the International Conventions and the National Law constitutes the legal framework for the protection the person of the woman and child. Article 264.- The following basic rules contained in international conventions, the Constitution and the National Law help to protect the family and the person of the woman - the family, the natural and fundamental unit of society, is protected by the State ensures its free development, as well as that of the mother and child by legislation and by appropriate social institutions; - On the basis of equality of men and women during pregnancy, childbirth and postpartum services appropriate and necessary, free as well as adequate nutrition during pregnancy and lactation; - The State recognizes the right of everyone to an adequate standard of living for himself and his family, including adequate food, clothing and adequate housing and to the continuous improvement of living conditions of existence and also the right to the highest attainable standard of physical and mental health attainable;

71 - the Malagasy Penal Code severely punishes anyone who helped or tried to promote abortion. Aggravated are penalties against members of the medical or paramedical personnel who have committed the same acts; - The Malagasy Penal Code contains, in Article 63 a provision to punish a person who willfully fails to bring another person in danger the assistance it could lend to him by his personal action, or causing a backup. This article applies to any medical body or the body of midwives would refrain from administering the necessary care to a woman at risk during childbirth. Article 265.- The following rules, devoting the best interests of the child had within the society contained in the International Conventions and the National Law ensure the protection and safeguarding of the physical and moral integrity children: - State recognizes that every child has the inherent right to life and provides the greatest extent possible the survival and development of the child; - The State undertakes to respect the right of the child to preserve its identity, name and family relations; - The State shall ensure that the child has access to a reversal to promote social well-being, spiritual and moral well being and physical and mental health; - The State protects children and adolescents against all forms of violence, injury or physical or mental abuse, neglect or negligent treatment, including abuse, violence and sexual exploitation that the law severely punished. In this perspective, the Malagasy Penal Code protects children against infanticide, physical harm to minors, violence or deprivation seriously affecting the health or physical integrity of a child;

- The child has the right to the highest attainable standard of health and to facilities for treatment and rehabilitation. The State strives to guarantee every child access to health services; - The State must take all appropriate measures to fight against disease and malnutrition, provide primary health care, ensure the provision of adequate nutritious foods and clean drinking water; - Child care in the family a special place: it has the right to moral and material security as complete as possible; - Responsibility for their education is primarily the family, however in case of failure, must be aided and assisted by the government. TITLE I HEALTH OF COPYRIGHT CHAPTER I PROVISIONS FOR MOTHERHOOD SAFER Article 266.- The health and welfare of pregnant women and mothers as well as children with no more than two (2) years of age is organized under conditions laid down by decree of the Council of the Government on proposal by the Minister responsible for the health. Article 267.- All practices that negatively impact on the evolution of pregnancy, childbirth, postpartum and postnatal period are punished punishment under the provisions of Article 346 of this Code.

72 The doctor has a duty to give advice to patients on the prevention of unwanted pregnancies. It is for the State to establish special health services, quality and accessible to women with complications of pregnancy, childbirth, postpartum, post natal period and that to abortion. Specifically, for the prevention of gynecological cancers, health facilities have a duty to make available to women aged twenty-five to fifty years the appropriate information for the cervical cancer prevention of cervical and breast cancer. The doctor has a duty to give advice to women on the prevention of gynecological cancers. Article 268.- Every woman has the right to benefit from a screening of cervical cancer by Visual Inspection with Acetic Acid (VIA) by Pap test at least once in his life. It is for the State to establish special health services accessible to women with cervical cancer and breast cancer in order to be available for: - diagnosis and - taking responsible for these cancers. CHAPTER II FAMILY PLANNING Article 269.- The Minister of Health, the Minister of Telecommunications, Posts and Communication and the Minister for Transport and Tourism is responsible for the sensitization of the population on health Reproduction. The Ministry of Health monitors the quality of training services. A further review of legislation and regulations relating to the sale, use of contraceptives and the publicity which they are subject must be made jointly by the ministries mentioned above plus the Ministry of Justice. CHAPTER III THE REPRODUCTIVE HEALTH OF YOUNG AND YOUNG Article 270.- The organizations providing health services targeting people aged ten to nineteen, say teenagers and those aged fifteen to twenty four years, said young people have the duty to make available to them appropriate information for the promotion of safe sexual behavior and responsible. CHAPTER IV ASSISTED REPRODUCTION MED AND GENETIC ENGINEERING Article 271.- Special health facilities and accessible to adolescents and young people are allowed to offer services of:

- Prevention and treatment of infections of the urinary and genital tract including sexually transmitted infections; and complications medico-surgical

73 related to induced abortions, teenage pregnancy, and inappropriate or unwanted pregnancy from acts of violence or other; - Prevention and treatment of infertility; - Premarital counseling; - Education for family life. Article 271 bis.- The human being and his environment must be protected against the abuse of medically assisted procreation and genetic engineering. The state, through the Ministry of Health, legislate on the use of the reproductive and human genetics. In doing so, it ensures the protection of human dignity of the person and of the family, including the following principles: - all forms of cloning and interference with the genetic heritage of gametes and embryos are prohibited; - The genetic and non-human reproductive material may neither be transferred into the human germline or merged with it; - The use of assisted reproductive methods is permitted only when sterility or the danger of transmission of a serious illness can not be removed in another way, and not to develop certain qualities in children or any end of eugenics and to satisfy research; - Fertilization of human eggs outside a woman's body is permitted only in accordance with the law; can not be developed out of the body of women into embryos that the number of human eggs can be implanted immediately; - Embryo donation and all forms of surrogacy are prohibited; - It can be made commercially human reproductive material or the products from embryos; - The genetic makeup of a person can not be analyzed, recorded and communicated with the consent of the latter or under an Act; - Everyone has access to data on ancestry. TITLE II THE HEALTH PROTECTION OF CHILDREN Article 272.- Under the coordination of the Ministry of Health, multisectoral actions which aim to fight against: • malnutrition of the mother and child; • the lack of food and economic security at the household level; • micronutrient deficiencies (disorders due to iodine deficiency, and iron deficiency anemia Avitaminosis ), contribute to the implementation of the National Policy of Nutrition PNN or adopted by regulation. This policy includes interventions or strategies such as promoting

Breastfeeding and complementary feeding, nutrition intervention at Community level, the integration of nutrition interventions in primary health care, care for severely malnourished children, intervention on the school nutrition, a national food and nutrition surveillance system. Article 273.- The Minister of Health is working closely with other departments concerned .

74 In partnership with various national and international organizations, is implementing the IMCI (Integrated Management of Childhood Illness). Article 274.- The National Health Policy contains two strategic axes concerning the Expanded Program on Immunization in Madagascar: the promotion and protection of health and the fight against disease. The objectives of the Expanded Programme on Immunisation include control disease to be the subject of prevention through vaccination, expanding access to immunization services to populations in rural and suburban areas to reduce the gaps and avoid the creation of high-risk areas to target patients to promote intersectoral collaboration and ensure the sustainability of the program. The implementation of the Expanded Program on Immunization is provided by relevant departments of the Ministry of Health. Article 274 bis.- The state, through the Ministry of Health must ensure complete assistance on health programs for children and adolescents, for the participation of non-governmental entities and respecting including following precepts: - allocation of a percentage of public funds for the mother and health care of children; - Creation of preventive and specialized care programs for people with motor disabilities, sensory or mental; - Creation of programs for the social integration of disabled and disadvantaged adolescents through specialized training and oriented towards their integration in working and community life; - Creation of specialized prevention and treatment programs for children and young people who use drugs and related drugs. TITLE III HEALTH SCHOOL AND UNIVERSITY Article 275.- The medical services are of concern to the health of students Universities, colleges and other institutions, public or private, top-level, as well as students and staff teacher of secondary schools, technical and basic education are organized by decree issued by the Council of Government on the proposal of the Minister of Health. The regulation thus provided must include provisions respecting - the remit of services; - Their place in the general organization of the Ministry and local authorities ; - The introduction of mandatory periodic medical examinations, subject to supervision and monitoring under the authority of the Ministry of Health; - The implementation of a policy to promote hygiene, sanitation academics and school infrastructure and good, nutrition and food safety; - The list of measures under the national health policy measures to strengthen programs, particularly for children, and to create, within communities as families, changes in behavior vis- à-vis the respect of collective hygiene; - Mandatory vaccination pout every child before his admission to a school;

75 - the requirement for all students to meet the mandatory vaccinations declared during schooling.

Article 276.- The Minister of Health is concerned with compliance and standards of "health school." The regulation thus provided must include provisions respecting - the standard installation and standard school health either at the level of medical services at the level of schools and universities; - Monitor their effective implementation at all levels; - Participation of the Committee for Hygiene and Health in the implementation of components of "health school" for sustainability; - Monitor their effective implementation in schools. The implementation modalities and application of the two preceding articles shall be specified by regulatory means. TITLE IV PROTECTION OF FAMILY AND SOCIAL RIGHTS CHILD Article 277.- In addition to the provisions of Law n ° 2007-023 of 20 August 2007 on the rights and protection of children from the birth, every child has the right to registration at the Civil Status. Without prejudice to the provisions of Law No. 61-025 of 9 October 1961 amended by Law No. 90-015 of July 1990 on the acts of civil status, births attended by doctors and midwives are required the latter, from the birth of the child or if, within a period not exceeding twelve days after birth, to send to the Registrar of Civil Status of the place of birth, a certificate indicating that the child's birth occurred on such a day, such time as determined location. The surname of the child chosen by the parent or parental authority recognized competent, should be included in the certificate. Article 278.- Without prejudice to the provisions of the Act relating to acts of Civil Status and those of civil law, the Officer of the Civil State and held, upon receipt of the certificate, write immediately the birth certificate and to sign with the registrant. However, in case of doubt about the authenticity of the statements contained in the certificate, the Civil Status Officer can monitor the fairness of the said declarations by a doctor or a midwife other than the declarant. The doctor or midwife in charge of control must come from a Public Health Facilities place of delivery or failing that, a Public Health Training closest to the place of delivery. More particularly, and to promote the protection of children's rights in cases of abuse suffered by the child, medical confidentiality must be lifted.

76 BOOK VII LABORATORY TITLE I LABORATORY MEDICAL ANALYSIS CHAPTER I. GENERAL PROVISIONS

Article 279.- Laboratory by means of medical analysis, any establishment whose main activity consists on prescription, or health workers, analyzes, laboratory tests and samples that enable to highlight a biological or physiological change, a pathogen or allergen agent and contribute to the diagnosis, treatment, prevention of disease, achieving a checkup or pregnancy observation. Article 280.- The opening and operation of a medical analysis laboratory are subject to authorization by the Minister of Health after consultation with the National Commission for opening and closing of private institutions. The license is issued to the laboratory owner's name if it is an individual or on behalf of the company owner and director of the laboratory, or the name of the hospital or care delivery, that it is public or private, in the case of a corporation including the name of the director of the laboratory. Article 281.- No one can own, establish, operate or run a medical laboratory if it does not have the required qualifications and did not meet the conditions defined in Book VII of the Code. The regulation sets up the elements of the request to open folder or exploitation, specifies the technical characteristics of the laboratory, equipment and staff. Any modification of one of the components of demand occurred during operation, in particular any change of director must be declared to the Minister for Health. Article 282.- The authorization was withdrawn by the Minister of Health when legal or regulatory conditions cease to be met or if the quality control analyzes carried out in the laboratory revealed repeated anomalies as regards their use medical. Article 283.- Any laboratory analysis is required to apply the principles and guidelines of good laboratory practices recognized by the Minister of Health. Article 284.- Any medical laboratory is subject to inspection measures carried out by inspectors pharmacists Medicines Agency Madagascar. The inspections are the subject of a report to be transmitted to the Department of Pharmacy, Laboratory of Traditional Medicine and the Ministry of Health. The Directorate and the Laboratory of Traditional Medicine reports to the Ministry of Health and proposes measures to be taken. Article 285.- Any advertisement for a medical laboratory is prohibited.

77 Only justified opening ads in a medical laboratory in the press and, for one (1) month from the date of the first announcement. A medical laboratory is publicly by professional plate affixed to the door of the premises and the building in which it is installed. The particulars to be included in the professional plate are the name of the laboratory, the name of the Director, his degrees or diplomas, specialties and days and hours. Article 286.- Any document from medical analysis laboratory must include the name of the laboratory, full address, the Director of the name, titles or diplomas. CHAPTER II OPERATIONS Section 1 The operating conditions Some medical laboratories Article 287.- A medical analysis laboratory can be opened, operated or managed by one the following entities:

1 a natural person; 2- a company comprising of civilians and professionals; 3- a limited company or a limited liability company; 4- a body or department within the State; 5- a non-profit organization of public utility or benefiting from an authorization granted by the Minister of Health. Article 288.- When the laboratory is operated by an individual, it is the laboratory director. When the laboratory is operated by a corporation in the form of professional company, all shareholders are directors of the laboratory. Three quarters of the share capital must be held by the Directors and Deputy Directors of the laboratory. The partners may be only natural persons, excluding those engaged in medical activities other than the Director or Deputy Director of the laboratory. The accession of a new partner is subject to the prior approval of the General Assembly by a majority of two thirds. The same company may operate only one laboratory. The same person can not hold units or shares in a company operating a laboratory. Article 289.- The Minister of Health, on the advice of a Joint Committee is empowered to make the setting and periodic review of the pricing of medical tests.

78 The medical laboratories are obliged to respect the minimum prices under the pricing. The fares must be displayed in the laboratory for public information. Article 290.- When the laboratory is operated by an agency of the State, the Director is appointed by decree of the Council of Ministers on proposal of the Minister of Health. Section 2 Provisions applicable to the directions of executives of medical laboratories Article 291.- No person may act as Director or Deputy Director of a medical laboratory if it meets the following conditions: 1- be of Malagasy nationality or national of a country with which a reciprocity agreement has been signed, and that, within a quota set each year by order of the Minister of Health; 2 holds a medical degree, pharmacist, veterinarian, biologist or scientist holds a diploma recognized by the Malagasy State for this activity; 3- justify specialized training, the nature and terms are set by law; 4- be on the roll of the professional order to which he belongs; 5- be resident in the laboratory implantation locality. Article 292.- The Directors and Deputy Directors of medical laboratories should personally carry out their duties. They may be responsible for more of a medical laboratory. They may not perform any other medical activity, pharmaceutical or veterinary. A medical laboratory must, in addition the Director and Deputy Director, at least two (2) laboratory technicians who can demonstrate specialized training and experience relevant to the analyzes. A Director or Deputy Director prevented may be replaced on a temporary basis under the conditions laid down by regulation. In case of death of the director of a clinical laboratory operated under individual form, his heirs can put the lab management for a period not exceeding two (2) years. The holder of management must fulfill the conditions set out in Article 291 above. CHAPTER III ANALYSIS

Article 293.- The medical analysis and sampling for analysis can only be performed in establishments approved for that purpose under the guidance of qualified personnel, subject to the provisions on medical practices and unless transitional derogation granted by the Minister for health for public health reasons.

79 Any analysis and any withdrawals made in the laboratory must be recorded in a register. All analyzes and reports all analyzes must be dated and bear the signature of the Director or Deputy Director or other qualified person designated laboratory in which the analyzes were performed. The test results can only be transmitted to a doctor and patient in no case, except in sealed envelopes for the doctor. Some analyzes, the list is fixed by decree of the Minister of Health, can only be carried out in laboratories approved for this purpose, whether private or public. The execution of certain medical tests may be permitted in private medical practices, within a list drawn up by decree of the Minister of Health. These analyzes should be performed by the physician or under his responsibility by a qualified technician of samples taken as part of a consultation. Equipment standards and the local hardware needed to run medical tests in private doctors' offices are determined by order of the Minister of Health. Physicians practicing medical tests in their offices can not under any circumstances use the reference laboratory for medical analyzes. The pricing of medical tests performed in a medical office must comply with the regulations. Article 294.- The medical laboratories of the public sector may have to perform on-demand scans practitioners or health facilities in the private sector, when these analyzes are restricted to certain public sector laboratories or for reasons of proximity in not provided with medical laboratory areas. TITLE II ORGANS AND SUBSTANCES OF HUMAN ORIGIN FOR INTERVENTION THERAPY, DIAGNOSIS OR FOR RESEARCH CHAPTER ONE GENERAL PROVISIONS Article 295.- The term therapeutic or diagnostic substance of human origin, any substance taken from a human being and for therapeutic or diagnostic purposes. The sale and use of therapeutic substances of human origin shall be governed by the provisions of the laws and regulations in force as well as those of this title and its implementing regulations. The levy of therapeutic substances of human origin can not be practiced without the prior consent of the donor, that consent may be withdrawn at any time. No physical pressure, moral or pecuniary should be behind the gift. 80

The donor must be informed in a precise and understandable to him by a doctor, the risks associated with certain levies. No payment in whatever form, can be allocated to one that lends itself to the removal of elements of the body or the collection of its products. Article 296.- The donor may not know the identity of the recipient, nor should the recipient of the donor. No information identifying both the one who donated a part or product of his body, and the one who received can not be disclosed. It may be departed from this principle of anonymity in cases of medical necessity, and with the agreement of the parties. Article 297.- Any advertisement for a donation of therapeutic substance of human origin in favor of a particular person or for the benefit of a particular organization is prohibited. This prohibition does not prevent informing the public in favor of organ donation and the human body products. Article 298.- The levy and collection of therapeutic substances of human origin for therapeutic purposes are subject to safety rules defined by decree of the Minister of Health. These rules include the communicable or sexually transmitted disease testing. The collection and use of therapeutic substances of human origin may only be made by a physician or under his direction. They can be made only on medical prescription. CHAPTER II BLOOD AND DERIVATIVES Article 299.- Blood transfusion is an act by which human blood is administered to a patient in therapy after treatment of said blood and consent of the recipient or his legal representative. This medical procedure involves the doctor prescribed the responsibility of the one who performs and people of the acting under his direction. The act involves subjecting the blood to a transaction or result of operations appropriate to confer optimal employment characteristics. Blood transfusion is done in the interest of the recipient, after the doctor has ensured its actual need, and raises ethical principles of volunteering and the anonymity of the donation, and the lack of benefit and should be bear a specific examination to confirm its safe nature under the conditions defined in this title. For the purposes of this Code, by blood transfusion means any administration of human blood and / or its derivatives to a patient for therapeutic purposes. Article 300.- The taking of blood or some of its components only, can not be done with the consent of the donor, by a physician or under the direction and responsibility of a physician who will be assured of the ability the donor. 81

Blood donation falls within the ethical principles of donor anonymity, volunteering and the absence of profit under the conditions defined in this title. No remuneration, other gain except days off, can not be allocated to the donor, without prejudice to the reimbursement of travel expenses, according to a tariff proposed by the institution and approved by the Minister of Health. No blood test for therapeutic use for others can take place over a person subject to a measure of legal protection. However in the case of minors, sampling can be performed exceptionally, when reasons of public emergency treatment required under condition of written consent of the recognized parental competent authorities. Article 301.- The blood, its components and their derivatives may not be distributed or used without it being made of biological analyzes and infectious disease testing, under conditions defined by decree of the Governing Council on a proposal the Minister for Health. Article 302.- The collection of human blood or blood components for therapeutic use can be done by a body or a blood transfusion establishment approved by the Minister of Health for these purposes. The technical approval may be granted only to an organization meets all the requirements defined by the regulations. It is granted for a fixed term and is renewable. The blood establishment concerned is subject to the technical, medical and health defined in the regulations. It must be organized taking into account the criteria of geographical, demographic and health planning. Article 303.- In case of blood transfusion to a patient identification, regardless of its condition, the blood transfusion bear a specific examination to confirm his reassuring character is mandatory. Article 304.- is created within the Ministry of Health a National Blood Transfusion Centre, abbreviated "CNTS" responsible for organizing the entire National Territory the collection, preparation, storage and distribution blood and its derivatives. Depending on requirements, as referred to in the previous article, the National Center for Blood Transfusion can be supported in its mission: • by Regional Centers of Blood Transfusion, abbreviated "ASIC" in hospital centers university and hospital centers regional Reference; • Post and Blood Transfusion abbreviated "PTS" in hospital centers of District Level 2. Regional Blood Transfusion Centres and Posts of Blood Transfusion are placed under the administrative authority of the National Blood Transfusion Centre. PTS operate as antennas of CRTS. The terms of organization and functioning of the National Transfusion Centre Blood of Regional Blood Transfusion Centres and Posts Blood Transfusion

82 are fixed by decree of the Government Council of Minister's proposal for Health. The blood establishments, CRTS and PTS, have a public health mission in the public service of blood transfusion. They are the only institutions authorized to collect blood or its components, to prepare blood products from the blood, and distribute under the direction and responsibility of a doctor or pharmacist. Only Directors may be appointed to the National Blood Transfusion Centre and

Blood establishments medical specialists in blood transfusion, or public health, or biology, or pharmacists on the Roll of the Ordre is included in by appearing on a reserve list. A decree of the Council of the Government on the proposal of the Minister of Health determines the conditions under which the short list is established, including specialized training and practical experience whose directors must justify. The Directors are appointed by decree of the Council of Ministers on proposal of the Minister of Health. The level of activity at CRTS and PTS can justify a function part-time Director. Article 305.- Each official establishment organizes, following the guidelines of the National Center for Blood Transfusion, the collection and distribution of blood and its derivatives in the application area. Distribution is done through the hospital stations or depots under its responsibility. No deposit can be organized outside a hospital. Each position or deposit is under the authority of a responsible physician. The level of activity at the deposit may justify a function responsible part-time. Article 306.- The import and export of human blood and its derivatives are reserved for the National Blood Transfusion Centre. If there are products prepared industrially, their list is established by decree of the Minister of Health. Only holders of approval establishments can ensure distribution throughout the national territory. Article 307.- The Minister of Health adopted by decree on the proposal of Director of the National Blood Transfusion Centre, regulations regarding: - the technical conditions for the determination of blood groups; - The tests for controlling the compatibility of the donor blood with the recipient and the precautions that must surround the use of blood and its derivatives; - Criteria of donor elections and periodic medical surveillance; - The conditions and sampling methods, preparation, storage, delivery human blood and its derivatives; - Standards of manufacturing and quality controls will respond manufactured and imported blood products; - Facilities and equipment necessary for blood transfusion;

83 - the establishment of each collection area; - Prices of sale of blood products. Article 308.- The Minister of Health approves the proposal of the Director National Blood Transfusion Centre the law that specifies the organization and functioning of the Blood Transfusion Centre on the entire national territory. This Regulation sets the modalities of the emergency department, transfusion and issuing of blood. Article 309.- blood transfusion institutions assume, in the absence of error they may have committed, responsibility for risks to donors on the occasion of sampling and also take steps to empowering donors to not transmit diseases to recipients. These institutions should contact their insurance covering liability for these risks. Article 310.- The Minister of Health designate inspectors from doctors or pharmacists qualified his department officials, who are responsible for ensuring compliance with laws and regulations applicable to blood establishments and controlling this particular title:

1- the conditions of preparation, preservation and delivery of blood products; 2- the application of good practices whose principles are defined by internal regulations established by the management of CNTS as part of the mission entrusted to him by the Minister of Health; 3- administrative and financial management of institutions. Article 311.- Any inspector CNTS has standing under the provisions of Article 199 of this Code in the field of the exercise of their functions listed under the provisions of Article 310 in supra. They are empowered to search and see for record violations of laws and regulations which they control the application. In the performance of their mission, they have access to the premises and records of blood establishments. They can at any time carry out the necessary checks to take place at least once a year. Article 312.- Any violation by a blood establishment, legislative and regulatory requirements applicable to it can cause temporary or permanent withdrawal of the technical approval. Withdrawal can only take place after formal notice to the institution to take all appropriate measures to remedy the violation or breach, or provide all necessary explanations. The setting remains fixed in an implementation period not exceeding three months. After this period, and failing that, by the holder of complying with the requirements arising from the notice, the Minister of Health may order the withdrawal of the technical approval. In case of emergency and for reasons relating to the protection of public health, the Minister of Health, after hearing the officials of the institution authorized blood transfusions, may order a reasoned decision provisionally the immediate closure of 84

the institution for a period not exceeding three (3) months. At the end of that period, the Minister of Health makes a final decision is notified by registered letter with acknowledgment of receipt to the institution authorized blood transfusions. If the closure of the institution authorized compromises blood supply of blood and blood derivatives in its corresponding amount to the needs of the country, the Minister of Health may take all urgent and necessary measures and appoint a provisional basis, a organization of national or foreign locum. CHAPTER III GRAFT AND TRANSPLANTS

BODIES AND SUBSTANCES Article 312 bis.- The state, through the Ministry of Health, shall issue regulations in the field of transplantation organs, tissues and cells. In doing so, it ensures the protection of human dignity of the person and health. It ensures a fair allocation of organs. The donation of organs, tissues and human cells is free. Trade in human organs is prohibited. The State shall legislate on the use of reproductive and genetic material of animals, plants and other organisms . In doing so, it respects the integrity of living organisms and the safety of humans, animals and the environment and protect the genetic diversity of animal and plant species. It shall be subjected without his free consent to medical or scientific experimentation.

Article 313.- The harvesting organs or tissues for transplantation or transplantation of a living human being, are prohibited until the sampling conditions, preparation, preservation and employment treatment are met and defined by a specific law. Samples can be performed for therapeutic or scientific purposes from the corpse of a person who, during his lifetime, was legally known in writing its agreement to such an operation. TITLE III CONTROL HANDLING OF PRODUCTS BASED MICROBIAL Article 314.- Anyone patented or not, preparing or even experimenting in a selfless purpose, attenuated virus, or not, therapeutic sera, toxins modified or not and various microbial products not chemically defined, which may serve, in any form, diagnosis, prophylaxis or therapy, is required to subscribe for itself and for the staff at its service in any capacity whatsoever, a declaration of civil status, nationality, domicile of each person, and the exact nature of the work entrusted to him.

85 Article 315.- Any change in the composition of the staff should be a statement of the same nature within eight days of the inauguration said staff after modification. Article 316.- A regulatory text later determine, if any, other information that may be required, under the penalties provided below regarding the operations relating to the products mentioned in section above. BOOK VIII RESPONSIBILITIES OF STAFF AND SERVICE PROVIDERS IN THE HEALTH ADMINISTRATION TITLE I CLASSIFICATION OF LIABILITY Article 317.- Without prejudice to the provisions of laws and regulations on liability and the resulting penalties, it is set up within the Ministry of Health a responsibility system involving staff and service providers. The different categories of liability assumed by the personnel of the Ministry of Health and by its service providers can be classified into: - general command responsibility; - Particular order responsibility; - Responsibility for personal. TITLE II RESPONSIBILITIES OF GENERAL Article 318.- These are obligations involving the responsibility of superiors principals. These responsibilities can only be moral or disciplinary. They only address the Minister, Members of the Cabinet, the Secretary General and the Managing Directors. This, notwithstanding the provisions of Articles 13, 14 and 15 of Law No. 2003-011 03 September 2003 General Statute of Officials and those of laws and regulations concerning finance and Public Accounting, in particular those of Law No. 2004-006 of 26 July 2004 on the reorganization and functioning of the Council of Budget and Financial Discipline. They are moral, to the extent that they result in a value judgment on staff who incur them. They are disciplinary, when the gravity of the facts giving rise to disciplinary action. TITLE III ORDER SPECIAL RESPONSIBILITIES Article 319.- These are the responsibilities defined by the laws and regulations. They focus on certain well-defined functions, namely: 86

- Those of officers; - Those managers and accountants. Article 320.- However, Directors and Heads of Service, as first

Responsible for their respective districts, are released from any of their responsibilities, in the responsibilities of their subordinates. They are responsible for the execution of orders they have given to their subordinates. Paid for them to report to their Supervisor of the execution of missions and in case if any, reasons that do not allow the execution of these missions. This facie evidence of the existence of force majeure or proven to exist or proven abuse of office committed by subordinates. Article 321.- For the officers, these responsibilities are disciplinary and criminal order; they can lead to fines imposed by a High Council of Financial Health with the creation, organization and operation are determined by Decree of the Council of the Government, on proposal of the Minister of Health. Article 322.- For managers and accountants, in addition to the sanctions referred to in supra these responsibilities are monetary and repayment can be translated either by a debit balance accounting made by order of the Minister of Finance and budget proposal on financial Superior Board of Health; either through a charge to the level of balances and accessories of the individual decision of the Superior Council of Financial Health, after prior visas from the Minister of Finance and Budget and Financial Control. Article 323.- The penalties are imposed by the Financial Supreme Council of Health, after studies of contentious issues, communications made in (the) applicant (s) and receipt of its (their) defense arguments. The decision, after visas of the Minister of Finance and Budget and Financial Control is applicable regardless of criminal decisions. The proceedings before the Courts did not suspend the implementation of the decision of the Financial Supreme Council of Health. This responsibility is independent pecuniary disciplinary sanctions and criminal which can also be pronounced. However, priority is given to the responsibility of a pecuniary nature, insofar as it is primarily the aim of full and complete financial compensation for damages suffered by the Ministry of Health. Article 324.- These responsibilities attributable to managers and accountants concern as the Directors and Heads of Service of the Ministry of Health performing functions of administrative and financial management. In all cases, these responsibilities have a co integral character to the extent that the primary responsibility is the lead author while his subordinates are co-authors. Article 325.- The provisions of Articles 321-324 in supra apply to the Health Sector stakeholders below: - Authorizing the Executive Directors or management activities; - Heads of Service Manager of activities; - Agents managers of activities; - Accounting; - The accounting custodians mobile equipment; - The accounting custodians checks fuels and lubricants; - Holders workforce;

87 - users of credit and fiduciary values; - Providers of medicines; - Service providers, medication management related partners without prejudice to the provisions of the concession contracts or any letters providing for an engagement or disengagement of responsibility. The provisions of this Code shall take precedence over those of any contract, agreement or concession of service established between the Ministry of Health and its service partners. TITLE IV

ORDER OF PERSONAL RESPONSIBILITIES Article 326.- These responsibilities involve all staff irrespective of the Ministry of Health, with the exception of supervisors listed in Article 318 above, if committed serious misconduct in the exercise or on the occasion of the exercise of their functions, including for embezzlement of public funds or convinced. Or when there is willful misconduct or fault characterized by technical service Like the deterioration or loss of service equipment, supplies or medical products. And especially when it is proved that the offense is a detachable fault of the service. Article 327.- In particular, besides the staff of the Ministry for Health, the above responsibilities also commit the partners providing service following benefits: - providers; - providers ; - Entrepreneurs; - Suppliers. BOOK IX PENALTIES AND DISCIPLINE OF BREAKING

TITLE OF PENALTIES Article 328.- All infractions to sanitary measures enacted in Chapters I, II and III of Title I of Book I of this Code, shall incur the penalties provided for in Article 329 and 330 below below the same Code, without prejudice to criminal prosecution under the criminal Code, and disciplinary proceedings that may result. Article 329.- All violations of the measures imposed by this Code is intended to protect against pollution of drinking water and environmental protection as well as for the monitoring of water and all food delivered to consumption, are punishable by imprisonment from one month to three and a half years and a fine of 150,000 ariary to 1,500.00 Ariary or one of these penalties. In case of recidivism, the penalties shall be doubled. Are also prohibited, on pain of the same penalties: - delivery for human consumption deemed non-potable water;

88 - fraud, forgery, marketing of food adulterated, corrupted or toxic products for falsifying food and incitement to forgery and attempts wrongdoing listed above . The above provisions refer to the principles of "polluter pays" on Law No. 98-029 of 20 January 1999 on the Water Code and Law No. 99-021 of 9 August 1999 policy management and control of industrial pollution. Article 330.- Any dealer of drinking water which, by inattention, negligence, carelessness, failure to comply with sanitary regulations or requirements of specifications caused the delivery of water drink likely to harm the health of the public or any polluter, is punished with a fine of 18,000 to 600,000 ariary ariary and imprisonment of one month to six months or one of these penalties, without prejudice the provisions of law No 98-029 of 20 January 1999 Water Code in the matter. In case of recidivism, the penalties shall be doubled. Article 331.- Any person who refuses to comply with emergency requisitions, addressed to him, by a qualified agent in his capacity as a public authority; as stipulated by Article 75 of this Code, is punished with a fine of 4,000,000 to 9,000,000 MGA MGA and imprisonment for six months to a year or one of these penalties. In case of recidivism, the penalties shall be doubled.

Article 332.- The illegal practice of the profession of doctor, acupuncturist, pharmacist or odonto- stomatologiste is punishable by a fine of MGA 2,000,000 50,000,000 ariary and imprisonment of one months to a year or one of these penalties. In case of recidivism, the penalties shall be doubled. It may also be pronounced the confiscation of medical equipment that allowed the illegal practice. Article 333.- The illegal practice of the profession of midwifery is punishable by a fine of 2,000,000 to 50,000,000 ariary ariary and imprisonment from one month to one year or one of these two penalties. In case of recidivism, the penalties shall be doubled. It can further be pronounced confiscation of equipment that allowed the illegal practice. In case of death occurring during the illegal practice of the profession of midwifery, author and co-authors are punished by a criminal penalty of hard labor for up to life imprisonment, in accordance with Article 304 last paragraph of the Penal Code. Article 334.- Any member of the medical and paramedical profession convinced of having done or having tried to make a false statement for entry in the Roll of the Order is liable to a fine of 120,000 to 1,200,000 ariary ariary and to imprisonment for one month to one year, or one of these penalties, without prejudice to criminal prosecution under the provisions of the criminal Code or this Code.

89 In case of recidivism, the penalties shall be doubled. Article 335.- The illegal practice of nursing is punishable by a fine of 2,000,000 to 50,000,000 ariary ariary and imprisonment from one month to three months, or one of these two penalties. In case of recidivism, the penalties shall be doubled. It may also be pronounced the confiscation of all equipment and accessories that allowed the illegal practice. Article 336.- The illegal practice of the profession of Sanitary Help is punishable by penalties for the illegal practice of the profession of midwifery or nursing. In case of recidivism, the penalties shall be doubled. Can also be ordered confiscation of medical equipment that allowed the illegal practice. The above provisions apply to anyone committing an offense in gear or convicted of illegally practicing the profession of traditional healer. Article 337.- Any pharmacist or doctor, who is accused of selling medical samples, or denounced to time by a consumer with respect to this offense is brought before the Council of the Association for violation of laws and regulations in pharmaceutical materials. Article 338.- Anyone who sells medical samples is punishable by a fine of 20,000 to 2,000,000 MGA MGA and for a subsequent offense to a fine determined twice, without prejudice to criminal proceedings. Any pharmaceutical company engaged in the possession and sale of drugs without the Marketing Authorisation is liable to a fine of 2,000,000 to 20,000,000 ariary ariary, without prejudice to criminal proceedings and other administrative sanctions. Article 339.- A penalty of imprisonment from five to ten years and a fine of 200,000 to 2,000,000 ariary ariary or one of these penalties: - those who transgress the texts of the provisions concerning the production, transport, import, export, possession, offering, sale, acquisition and use of poisonous substances or plants classified as narcotic or psychotropic as well as any act relating in such transactions;

- Those who knowingly establish drug careless prescribing high risk; - Those who, knowing the fictitious or bogus of a given order, have on their presentation which was made issued high-risk drugs; - Those who, through fictitious order or complacency, made themselves issue or tried to be issued high-risk drugs; - Those sold or offered for high-risk drugs to a person for personal consumption of the latter;

90 - those who transgress legal provisions concerning the production, manufacture, extraction, preparation, processing, import, export, supply, sale, distribution , sale, delivery on any terms whatsoever, purchase, possession or use of drugs listed in tables II and III international conventions; - Those who facilitate drug delivery for medical, drug and hazardous or toxic without prescription.

In case of recidivism, the penalties shall be doubled. The provisions of this Article shall apply without prejudice to other penalties provided for not otherwise provided in the Code of Health, including those relating to narcotic drugs, psychotropic substances and precursors. Article 340.- Whoever knowingly book to the illicit sale of drugs without gather requirements for the lawful exercise of the pharmacy by transgression of Article 155 is liable to a fine of 2,000,000 to MGA 50,000,000 ariary and by imprisonment of three months to three years or one of these penalties. In case of recidivism, the penalties shall be doubled. Ruled by law, the confiscation of all equipment and medication that allowed illegal practice of pharmacy function. The provisions of this section do not apply to the depositary of medicines authorized to operate a deposit on order issued by the Ministry of Health, except in cases of infringement of Articles 202 to 204 of this Code. Article 341.- Anyone who makes a false statement for its inclusion in Schedule of the Order of Pharmacists was fined 120,000 ariary ariary 1,200,000 and imprisonment for six months to a year or one of these penalties, without prejudice to the sanctions provided in the matter. In case of recidivism, the penalties shall be doubled. Article 342.- Anyone who has violated the provisions on community pharmacies is punished with a fine of 200,000 to 2,000,000 MGA MGA and, for a subsequent offense, to a fine determined twice, without prejudice lawsuits. Article 343.- Any resistance, any opposition or any obstacle to the exercise of the function pharmacists inspectors are punished with imprisonment from six months to three years and a fine of 20,000 to 500,000 ariary ariary or one of these penalties, without prejudice to the punishment that may be imposed by the Council of the Order or administrative suspension or withdrawal of authorizations that may be taken by the Minister of Health to against the offender. Article 344.- All offenses relating to the advertising of medicines for human use, without prejudice to administrative sanctions shall incur the penalties provided for by Ordinance No. 73-055 of September 11, 1973 on the repression of offenses price system and intervention in economic matters.

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Article 345.- Infringements on the advertising ban on Care Institutions are liable to a fine of 500,000 to 1,000,000 MGA MGA and imprisonment of one month to one year of one of these two penalties. In case of recidivism, the penalties shall be doubled. It may also be pronounced the temporary or permanent closure of the establishment offender. The same penalties are applicable for infringement of the prohibitions listed in the provisions of Article 89 of this Code. Article 346.- A medical practitioner, midwife, other professional Health while comparing while declaring or any witness who, when writing a birth certificate, to have fraudulently misrepresented the substance or circumstances, either by writing other statements other than those which would have been traced or dictated by the parties or by finding as true of false facts or as to admit facts which were not, are liable to the penalties provided for in Articles 145, 146, 147 and 148 of the Penal Code of June 30, 1998 according to the nature of the offenses, without prejudice to the provisions of Law No. 61-025 of 9 October 1961 relating to acts of Civil Status, amended by Law No 90-015 of 20 July 1990 and any other subsequent amendments. The same penalties apply to any individual or posing attempters impersonating a doctor, midwife or other professional Health to establish a birth certificate. They are also applicable in case of commission of the provisions of Article 267 of this Code . Article 347.- The illegal use of the appellation of medical analysis laboratories or phrase confusing therewith, shall be punished with imprisonment of three months to three years and a fine of 50,000 ariary to 500,000 ariary or one of these penalties. In case of recidivism, the penalties shall be doubled. Article 348.- In the field of blood transfusion, be liable to criminal prosecution the facts listed below: - traffic of his own blood; - Drawing blood without the informed consent of the donor; - Blood donation against payment; - The use of blood and its derivatives that have not been pre analyzes; - The change or attempt to change the results at the end of blood tests; - The disclosure of information identifying the donor or the recipient; - the collection, processing and delivery of blood and its derivatives outside an approved body; - To yielding blood or blood products at different price that determined by regulations governing the matter.

92 Article 349.- The offenses set forth in the preceding article are punished: - by imprisonment of one (1) to six (6) months and a fine of 40,000 ariary 200,000 ariary or one of these penalties: • of his own blood trafficking; • blood sampling without concretely informed of the donor; • blood donation against payment; - By imprisonment of three (3) months to two (2) years and a fine of 100,000 to 400,000 ariary ariary or one of these penalties: • usage blood and its derivatives have not been the subject of prior analysis; • modification or attempt to change the results at the end of blood tests; • sampling, processing and issuing of blood and its derivatives outside an approved body; • to yielding blood or blood products at a different price than that fixed by regulations governing the matter.

TITLE II DISCIPLINARY Article 350.- The disciplinary sanctions imposed by this title shall apply, in case of translation at the Council of the Order of belonging, regardless of any decision of the Disciplinary Council public service. The disciplinary punishments that the Councils of the Order of members of the medical and paramedical professions can apply are: - warning; - the blame ; - Temporary disqualification for a maximum period of three years; - Removal from the Roll of the Order. Article 351.- All claims based on membership in the College, all electoral disputes within the Council of the Order of belonging, all disciplinary sanctions against a practitioner by the College membership may be subject to a prior request to the Ministry of Health conducts a deliberation session through the Disciplinary Committee stipulated in Article 352 below. Where matters of the Ministry of Health within forty (40) days of the request or plea explicitly expressed, the practitioner concerned may bring an appeal before the Administrative Chamber. However, an appeal to the Administrative Chamber is not suspensive. Article 352.- The Ministry for Health, entered by the Sanitary or judicial authority or by a practitioner or a interested union may establish by decree the creation of a Disciplinary Committee of Health Orders (CDSO ) responsible for deciding on whether or not to dissolve the Code of ethics of the Order concerned.

93 instead and instead of a dissolved Council, the Minister of Health shall designate by ministerial decision, a provisional delegation to deal with current business until the election of a new Council. Members of a dissolved assigned counsel are not eligible for three (3) years. The provisions of this Article shall apply in case of finding of abuse of authority committed by the person Order in applying the provisions of Article 350 above. The Commission on Health Discipline for Orders must be composed as follows: • the Secretary General of the Ministry of Health or his representative, Chairman; • Two members of the Cabinet of the Ministry of Health, a magistrate appointed by the Minister of Justice, Minister of Justice, two members appointed by each legally established order, but selected out of the members of the permanent office of the Council of Order that means. Once its mission is complete, the Disciplinary Committee of Health Orders and constituted, is dissolved automatically. If a new referral to settle another dispute, a new Commission composed of members above is established in the same form and the same conditions for a new temporary mission. Article 353.- Without prejudice to the sanctions provided for in this Code, the usurpation of title member of the medical and paramedical professions or other title to exercise the art of health professionals is punishable by penalties the provisions of the Penal Code in this regard. BOOK X MISCELLANEOUS AND TRANSITIONAL Article 354.- Minutes infringements of the provisions of this Code are addressed: - by doctors or pharmacists invested by this Code of inspection powers and participating in that capacity to the judicial police in the limit their functions; - By the competent administrative authorities in the regions;

- By officials such as controllers markets or health inspectors, municipal architects and all other officers authorized by the Ministry of Health, with respect to their functions or their technical competence.

The staff of the Police and the Gendarmerie who as officers or agents of the judicial police have the authority to draw up those minutes as part of their normal duties they hold the Code of Penal procedure.

94 Article 355.- Considering the actual existence of separate units of specialized training doctors, odonto- dentists and pharmacists, and unless special permission granted by the Minister of Health, each member of a medical, pharmacist or odonto- stomatologiste must exercise his art within the limits of his training and abilities that confer diplomas he holds. The exceptional authorization received from the Ministry in charge can not be justified by the absence or temporary disability of a member of a body whose art may be exercised by a member of a another body, and this in respect everyone's right to have access to medical care or medications. The implementing rules of this Article are specified by regulation. Article 356.- On pain of nullity of acts of recognition, the authorized authorities or agents to perform must be sworn. Article 357.- Medical inspectors, doctors clinics heads, fixed or mobile , chief medical officers of health offices may be required by administrative authorities as offenses as an expert. Article 358.- A transitional basis, changes in the distribution and the name, field of activity, the boundaries of Hospital Establishments and care centers, reference centers for primary care and second appeal are fixed. : - By decree of application of this Act on the Code of Health; - Or by any statutory instrument establishing the powers of the Minister of Health as well as the general organization of his Ministry.

As a transitional measure in this Code, the distribution and the name, field of activities and the above listed boundaries remain unchanged. It is the same for the current name of the existing institutions within the Ministry of Health. Article 359.- All previous provisions with those of this Act, including those of Ordinance No. 62-072 of September 29, 1962 as well as its amendments thereto, are and remain abrogated.

95 Article 360.- In accordance with Article 4 of Ordinance No. 62-041 of 19 September 1962 on general provisions of internal law and private international law, this Act comes into force on the whole extent of the territory of the Republic on the date of signature, once broadcast on radio and television waves national, regardless of its inclusion in the Official Gazette of the Republic and the publication of its implementing regulations. It will be enforced as a law of the state. Antananarivo, May 27, 2011 THE PRESIDENT OF THE BOARD OF TRANSITION, THE PRESIDENT OF THE CONGRESS OF THE TRANSITION

Rasolosoa Dolin RAHARINAIVO Andrianantoandro

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